EU Food Law: Protecting Consumers and Health in a Common Market 9781472563880, 9781841134987

Citation preview

(A) MacMaolin Prelims

9/2/07

15:15

Page v

In memory of Gaye

(A) MacMaolin Prelims

9/2/07

15:15

Page vi

(A) MacMaolin Prelims

9/2/07

15:15

Page vii

Acknowledgements There are several people who assisted in the preparation and publication of this book. I am very grateful to all of them. I would like to thank Professor John Usher, Ms Barbara Powell and Mr Patrick Overy of Exeter University; Professor Damian Chalmers, London School of Economics; Professor Hilary Delaney, Professor Gerry Whyte and Dr Eoin O’Dell of Trinity College, Dublin; Professor Gerrit Betlem, Southampton University; Dr Alan Dignam, Queen Mary, University of London; and Dr Adam McAuley, Dublin City University – who first suggested this topic as a research area. I am particularly grateful to Dr David Tomkin for meticulously reading through drafts and proofs and making numerous suggestions. His influence and expertise have greatly improved this book. My wife Síofra, my children Rían, Cathal and Donncha, and my parents Mícheal and Josephine, have all been most supportive and encouraging throughout. I would like to thank all at Hart Publishing for making the authorship process so enjoyable. Inevitably no text can be error-free, and any errors or omissions that remain are solely attributable to the author who invites comments and suggestions, and can be contacted by email at [email protected].

(A) MacMaolin Prelims

9/2/07

15:15

Page viii

(A) MacMaolin Prelims

9/2/07

15:15

Page xv

Table of Cases EUROPEAN COURT OF JUSTICE AND COURT OF FIRST INSTANCE 7/1968, Commission v Italy (art exports) [1968] ECR 423 ....................................60 24/1968, Commission v Italy (statistical levy) [1969] ECR 193 .............................60 2/1969 and 3/1969, Sociaal Fonds voor de Diamantarbeiders v SA Ch Brachfeld & Sons [1969] ECR 211 .......................................................................60 84/1971, SpA Marimex v Ministero delle Finanze [1972] ECR 89..........................60 8/1974, Procureur du Roi v Benoît and Gustave Dassonville [1974] ECR 837......................................................................................................20–4, 42 12/1974, Commission v Germany (sekt) [1975] ECR 181 ..................31, 113, 121–2 4/1975, Rewe-Zentralfinanz eGmbH v Landwirtschaftskammer [1975] ECR 843................................................................................................................63 87/1975, Conceria Daniele Bresciani v Amministrazione Italiana delle Finanze [1976] ECR 129..................................................................................18, 60–61, 64 104/1975, De Peijper (Centrafarm) [1976] ECR 613 ..............................................46 Case 46/1976, Bauhuis v Netherlands [1977] ECR 5 .................................18, 60, 61 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein (cassis) [1979] ECR 649 .........................................4, 17, 22–9, 32, 33, 35, 40–41, 45, 67–8, 70, 75, 95, 102, 116, 119, 130–1 168/1978, Commission v France (spirit tax) [1980] ECR 347 ................................58 170/1978, Commission v UK (wine and beer tax) [1983] ECR 2265..........................................................................................18, 34, 58, 118 88/1979, Criminal proceedings against Siegfried Grunert [1980] ECR 1827 ........213 788/1979, Criminal proceedings against Gilli and Andres [1980] ECR 2071.................................................................................................5,17, 23–4 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839 ....................................................................5, 17, 24, 28, 36, 39, 42, 116 53/1980, Officier van Justitie v Koninklijke Kaasfabriek Eyssen BV [1981] ECR 409........................................................................................................48, 212 193/1980, Commission v Italy (vinegar) [1981] ECR 3019..............................................................................5, 17, 26–7, 31, 35, 92 249/1981, Commission v Ireland (Buy Irish Campaign) [1982] ECR 4005...........29 261/1981, Walter Rau Lebensmittelwerke v De Smedt PVBA [1982] ECR 3961........................................................................................................28, 33 286/1981, Criminal proceedings against Oosthoens Uitgeversmaatschappij BV [1982] ECR 4575............................................................................................25 94/1982, Criminal proceedings against De Kikvorsch GroothandelImport-Export BV [1983] ECR 947 ...................................................................271

(A) MacMaolin Prelims

9/2/07

15:15

Page xvi

xvi Table of Cases 174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445..................................................................................47, 51, 53, 239, 271 222/1982, Apple and Pear Development Council v KJ Lewis Ltd and others [1983] ECR 4083 .......................................................................................29 227/1982, Criminal proceedings against Leendert van Bennekom [1983] ECR 3883..............................................................................................................50 237/1982, Jongeneel Kaas BV and others v Netherlands and other [1984] ECR 483..........................................................................................................29–30 314/1982, Commission v Belgium (imported poultry meat) [1984] ECR 1543..................................................................................................18, 61, 64 16/1983, Criminal proceedings against Karl Prantl [1984] ECR 1299................................................................................................28, 31, 122 96/1984, Vereniging Slachtpluimvee-Export eV v Rewe-ZentralAktiengesellschaft [1985] ECR 1157.....................................................................89 176/1984, Commission v Greece (beer) [1987] ECR 1193 ......................................52 178/1984, Commission v Germany (bier) [1987] ECR 1227 ............................3, 4, 17, 33–4, 35, 47–8, 55, 75, 91, 92, 116, 118, 239 182/1984, Criminal proceedings against Miro BV [1985] ECR 3731..........30–33, 92 216/1984, Commission v France (milk substitutes) [1988] ECR 793......................................................5, 17, 36–8, 39, 46, 48–9, 56, 126, 239 247/1984, Criminal proceedings against Léon Motte [1985] ECR 3887........................................................................................47, 211, 213–14 304/1984, Criminal proceedings against Claude Muller [1986] ECR 1511........................................................................................47, 211, 214–15 184/1985, Commission v Italy (banana consumption tax) [1987] ECR 2013 .......59 193/1985, Cooperativa Co-frutta Srl v Amministrazione delle finanze dello Stato [1987] ECR 2085................................................................................59 261/1985, Commission v UK (milk and cream) [1988] ECR 547 ..........................46 355/1985, Driancourt v Cognet [1986] ECR 3231...................................................25 407/1985, Glocken GmbH and Kritzinger v USL Centro-Sud and Provincia autonoma di Bolzano [1988] ECR 4233 ..............................35, 49, 56, 91, 92, 115 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021......................................................................................17, 38–9, 56, 126 90/1986, Criminal proceedings against Zoni [1988] ECR 4285..................................................................35–6, 40, 49, 91, 92, 115, 116 98/1986, Criminal proceedings against Arthur Mathot [1987] ECR 809............5, 25 286/1986, Ministère public v Gérard Deserbais [1988] ECR 4907............................................................................5, 17, 41–4, 91, 92, 172 18/1987, Commission v Germany [1988] ECR 5427...........................................61–3 274/1987, Commission v Germany (meat products) [1989] ECR 229....................................................................................5, 17, 45–6, 56, 239 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489 ......................................5, 17, 27–9, 41–4, 79-80, 91, 92, 171–2 C-67/1988, Commission v Italy (sesame oil) [1990] ECR I-4285 ..........................32

(A) MacMaolin Prelims

9/2/07

15:15

Page xvii

Table of Cases xvii C-362/1988, GB-INNO-BM v Confédération du commerce Luxembourgeois [1990] ECR I-667............................................................115, 271 C-95/1989, Commission v Italy (added nitrate) [1992] ECR I-4545 ...................211 C-196/1989, Criminal proceedings against Enzo Nespoli and Giuseppe Crippa [1990] ECR I-3647...............................................................39–41, 43, 116 C-238/1989, Pall Corp v Dahlhausen & Co [1990] ECR I-4827 ..................115, 271 C-369/1989, Piageme and others v BVBA Peeters [1991] ECR I-2971.....................................................................................................80–81 C-42/1990 Criminal proceedings against Jean-Claude Bellon [1990] ECR I-4863...........................................................................................211, 212–13 C-47/1990, Établissements Delhaize frères et Compagnie Le Lion SA v Promalvin SA and AGE Bodegas Unidas SA [1992] ECR I-3669 ...................................8, 107 C-344/1990, Commission v France (cheese nitrate) [1992] ECR I-4719 .........................................................................................50, 51, 52, 76 C-355/1990, Commission v Spain (conservation of wild birds) [1993] ECR I-4221.............................................................................................200 C-3/1991, Exportur SA v LOR SA and Confiserie du Tech SA [1992] ECR I-5529.........................................................................................107, 120, 121 C-126/1991, Schutzverband gegen Unwesen in der Wirtschaft eV v Yves Rocher [1993] ECR I-2361.................................................................115, 271 C-212/1991, Angelopharm GmbH v Freie Hansestadt Hamburg [1994] ECR I-171...........................................................................................................202 Joined Cases C-267/1991 and C-268/1991, Criminal proceedings against Keck and Mithouard [1993] ECR I–6097......................................................20, 86 C-285/1992, Criminal Proceedings against Coöperatieve Zuivelindustrie ‘Twee Provinciën’ WA [1993] ECR I-6045..........................................................80 C-315/1992, Verband Sozialer Wettbewerb eV v Clinique Laboratoires SNC et Estée Lauder Cosmetics GmbH [1994] ECR I-317 ........................115, 271 C-17/1993, Criminal proceedings against Van der Veldt [1994] ECR I-3537.........................................................................................................239 Joined Cases C-69/1993 and C-258/1993, Punto casa SpA v Sindaco del Comune di Capena et Comune di Capena and Promozioni Polivalenti Venete Soc coop arl (PPV) v Sindaco del Comune di Torri di Quartesolo and Comune di Torri di Quartesolo [1994] ECR I-2355.....................................20 C-144/1993, Pfanni Werke Otto Eckart KG v Landeshauptstadt München [1994] ECR I-4605...........................................................................................84–5 C-156/1993, European Parliament v Commission [1995] ECR I-2019 ........260–261 Joined Cases C-427/1993 and C-436/1993, Bristol Myers Squibb v Paranova [1996] E.C.R. I-3457 .............................................................................8 C-456/1993, Zentrale zur Bekämpfung unlauteren Wettbewerbs eV v Privatkellerei Franz Wilhelm Langguth Erben GmbH & Co KG [1995] ECR I-1737.................................................................................................115, 271 C-470/1993, Verein gegen Unwesen in Handel und Gewerbe Köln eV v Mars GmbH [1995] ECR I-1923 ...............................................................115, 271

(A) MacMaolin Prelims

9/2/07

15:15

Page xviii

xviii Table of Cases C-51/1994, Commission v Germany (sauces and pastries) [1995] ECR I-3599.....................................................................................................48, 86 C-85/1994, Piageme and others v Peeters NV [1995] ECR I-2955 .....................81–2 C-313/1994, Graffione SNC v Ditta Fransa [1996] ECR I-6039 ..........................271 Joined cases C-321/1994, C-322/1994, C-323/1994 and C-324/1994, Criminal proceedings against Jacques Pistre, Michèle Barthes, Yves Milhau and Didier Oberti [1997] ECR I-2343 ............................................25, 107 Joined cases C-34/1995, C-35/1995 and C-36/1995 Konsumentombudsmannen (KO) v De Agostini (Svenska) Förlag AB and TV-Shop i Sverige AB [1997] ECR I-3843...........................................................................................................20 C-317/1995, Canadane Cheese Trading AMBA and Adelfi G. Kouri Anonymos Emoriki Kai Viomichaniki Etaireia v Hellenic Republic [1997] ECR I-4681.............................................................................44, 91–3, 118 C-358/1995, Tommaso Morellato v Unità sanitaria locale (USL) n. 11 di Pordenone [1997] ECR I-1431.............................................................................50 C-368/1995, Vereinigte Familiapress Zeitungsverlags- und vertriebs GmbH v Heinrich Bauer Verlag [1997] ECR I-3689..........................................................20 C-388/1995, Belgium v Spain [2000] ECR 3123 ...............................................106–7 C-17/1996, Badische Erfrischungs-Getränke & Co KG v Land BadenWürttemberg [1997] ECR I-4617 ......................................................................125 C-18/1996, United Kingdom v Commission (BSE) [1998] ECR I-2265.........................................................................................196, 197, 199 C-157/1996, The Queen v National Farmers’ Union and others [1998] ECR I-2211 .................................................................52, 54, 196, 197, 199 C-184/1996, Commission v France (foie gras) [1998] ECR I-6197 ...........25, 42, 44 T-199/1996, Laboratoires pharmaceutiques Bergaderm SA and Jean-Jacques Groupil v Commission [1998] ECR II-2805 ......................................................199 C-210/1996, Gut Springenheide GmbH and Rudolf Tusky v Oberkreisdirektor des Kreises Steinfurt – Amt für Lebensmittelüberwachung [1998] ECR I-4657...........................................................................................115, 270–71 Joined Cases C-289/1996, C-293/1996 and C-299/1996, Denmark, Germany and France v Commission [1999] ECR I-1541 ................26, 29, 109–16 C-385/1996, Criminal proceedings against Hermann Josef Goerres [1998] ECR I-4431...............................................................................................82 C-77/1997, Österreichische Unilever GmbH v Smithkline Beecham Markenartikel GmbH [1999] ECR I-431.............................................................50 C-87/1997, Consorzio per la tutela del formaggio Gorgonzola v Käserei Champignon Hofmeister GmbH & Co KG and Eduard Bracharz GmbH [1999] ECR I-1301...........................................................................119–20 T-109/1997, Molkerei Grobbraunshain GmbH and Bene Nahrungsmittel GmbH v Commission [1998] ECR II-3533........................................................113 Joined cases C-129/1997 and C-130/1997, Criminal proceedings against Yvon Chiciak and Fromagerie Chiciak and Jean-Pierre Fol [1998] ECR I-3315...................................................................................................120–21

(A) MacMaolin Prelims

9/2/07

15:15

Page xix

Table of Cases xix C-383/1997, Criminal proceedings against Arnoldus van der Laan [1999] ECR I-731...........................................................................................39–40 C-312/1998, Schutzverband gegen Unwesen in der Wirtschaft eV v Warsteiner Brauerei Haus Cramer GmbH & C. KG [2000] ECR I-9187............................108 C-366/1998, Criminal proceedings against Yannick Geffroy and Casino France SNC [2000] ECR I-6579 ..................................................................................82–3 C-448/1998, Criminal proceedings against Jean-Pierre Guimont [2000] ECR I-10663.................................................................................................25, 117 C-465/1998, Verein gegen Unwesen in Handel und Gewerbe Köln eV v Adolf Darbo AG [2000] ECR I-2297 ...........................................................11, 271 T-13/1999, Pfizer Animal Health SA v Council [2002] ECR II-3305 .......................................................................................196, 198–203 T-70/1999, Alpharma Inc v Council [2002] ECR II-3495.....................................198 C-269/1999, Kühne and others [2001] ECR I-9517..............................................110 T-114/1999, CSR PAMPRYL v Commission [1999] ECR II-3331 .......................105 C-12/2000, Commission v Spain (chocolate) [2003] ECR I-459 .............................9 C-14/2000, Commission v Italy (chocolate) [2003] ECR I-513 ...............................9 C-24/2000, Commission v France (fortified foods – ‘Red Bull’) [2004] ECR I-1277 .......................................................................50, 51, 52–5, 64, 76, 239 C-123/2000, Criminal proceedings against Christina Bellamy and English Shop Wholesale SA [2001] ECR I-2795...................................................46–7, 239 C-221/2000, Commission v Austria (health claims) [2003] ECR I-1007...........................................................................................50, 227, 230 Joined cases C-421/2000, C-426/2000 and C-16/2001, Renate Sterbenz and Paul Dieter Haug [2003] ECR I-1065 ..................................................11, 271 C-95/2001, Criminal proceedings against Greenham and Abel [2004] ECR I-1333...............................................................................................50–52, 55 C-108/2001, Consorzio del Prosciutto di Parma and Salumificio S Rita SpA v Asda Stores Ltd and Hygrade Foods Ltd [2003] ECR I-5121 ..................120 C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693 ...................................................................................51, 52, 53, 54, 64 C-236/2001, Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others [2003] ECR I-8105 ........................................52 C-420/2001, Commission v Italy (caffeine energy drinks) [2003] ECR I-6445.....................................................................................................50, 54 C-14/2002, ATRAL SA v Belgium [2003] ECR I-4431 ...........................................50 C-41/2002 Commission v Netherlands (fortified foods) [2004] ECR I-11375 ......17 C-239/2002, Douwe Egberts NV v Westrom Pharma NV and Christophe Souranis [2004] ECR I-7007........................................................................11, 271 C-270/2002, Commission v Italy (sports supplements) [2004] ECR I-1559 .........50 Joined Cases C-465/2002 and C-466/2002, Germany and Denmark v Commission, [2005] ECR I-9115.............................................26, 34, 112–16, 117 C-366/2004, Georg Schwarz v Bürgermeister der Landeshauptstadt Salzburg, [2005] ECR I-10139.............................................................................55

(A) MacMaolin Prelims

9/2/07

15:15

Page xx

xx Table of Cases

UNITED KINGDOM Thoburn v Sunderland City Council; Hunt v London Borough of Hackney; Harman and Dove v Cornwall County Council; Collins v London Borough of Sutton [2002] EWHC 195; [2003] QB 151 ......................................88

(A) MacMaolin Prelims

9/2/07

15:15

Page xxi

Table of Legislation EUROPEAN UNION EC Treaty Article 6 ..............................................................................................................197–8 Article 25 ......................................................................................................18, 57–64 Article 28 ......................................................5, 9, 12–13, 15, 17–56, 64-5, 68, 69, 71, 72, 73, 74–7, 92, 118, 121–2, 211–12, 214, 237, 240 Article 29.........................................................................................5, 15, 68, 121, 211 Article 30........................................................5, 13, 15, 21, 40–41, 45–55, 65, 68, 71, 121, 122, 212–13, 214, 215, 233, 241, 277 Article 37 ........................................................................................................183, 260 Article 90 ................................................................................................17–18, 57–59 Article 94 ..................................................................................................................68 Article 95 ..................................................................................................68, 197–198 Article 151 ................................................................................................................65 Article 152.......................................................................21, 65, 197–8, 201, 241, 277 Article 153...........................................................................................21, 65, 241, 277 Article 174 ..........................................................................................................196–7 Article 202 ..............................................................................................................183 Article 211 ..............................................................................................................201 Article 230 ..................................................................................................26,109,198 Article 251 ..................................................................................................226–7, 240

Regulations Regulation (EEC) No 2772/1975 of the Council of 29 October 1975 on marketing standards for eggs [1975] OJ L 282/56 ...........................................267 Council Regulation (EEC) No 1898/1987 of 2 July 1987 on the protection of the designations used in marketing of milk and milk products [1987] OJ L 182/36 ..................................................................................37–9, 126 Council Regulation (EEC) No 2658/1987 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff [1987] OJ L 256/1 ................................................................................34, 111, 114 Council Regulation (EEC) No 1576/1989 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks [1989] OJ L 160/1.....................................................................................30

(A) MacMaolin Prelims

9/2/07

15:15

Page xxii

xxii Table of Legislation Council Regulation (EEC) No 1906/1990 on certain marketing standards for poultry [1990] OJ L 173/1 ...........................................................................273 Council Regulation (EEC) No 1907/1990 of 26 June 1990 on certain marketing standards for eggs [1990] OJ L 173/5 ...............................267–70, 276 Commission Regulation (EEC) No 1274/91 of 15 May 1991 introducing detailed rules for implementing Regulation (EEC) No 1907/90 on certain marketing standards for eggs [1991] OJ L 121/11...............................268 Commission Regulation (EEC) No 1538/1991 of 5 June 1991 introducing detailed rules for implementing Regulation (EEC) No 1906/1990 on certain marketing standards for poultry [1991] OJ L 143/11......................273–4 Council Regulation (EEC) No 2092/1991 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [1991] OJ L 198/1 ..........5, 255–61, 269 Commission Regulation (EEC) No 1535/1992 of 15 June 1992 amending Annexes I and III of Council Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [1992] OJ L 162/15 ..........................255 Council Regulation (EEC) No 2081/1992 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [1992] OJ L 208/1...............................34, 91, 93, 102–8, 110, 117, 137–8, 150 Council Regulation (EEC) No 2082/1992 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs [1992] OJ L 208/9 ..........................................................................................................117 Commission Regulation (EEC) No 207/1993 of 29 January 1993 defining the content of Annex VI to Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs and laying down detailed rules for implementing the provisions of Article 5 (4) thereto [1993] OJ L 25/5 ........260 Council Regulation (EEC) No 315/1993 of 8 February 1993 laying down Community procedures for contaminants in food [1993] OJ L 37/1 ........205–6 Council Regulation (EC) No 2991/1994 of 5 December 1994 laying down standards for spreadable fats [1994] OJ L 316/2..........................................127–9 Council Regulation (EC) No 1935/1995 of 22 June 1995 amending Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [1995] OJ L 186/1 ......................................................................................255, 264 Commission Regulation (EC) No 1107/1996 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/1992 [1996] OJ L 148/1...........................................109, 119, 120 Commission Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the Register of protected designations of origin and protected geographical indications provided for in Council

(A) MacMaolin Prelims

9/2/07

15:15

Page xxiii

Table of Legislation xxiii Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [1996] OJ L 327/11...........................................................................106 European Parliament and Council Regulation (EC) No 258/1997 of 27 January 1997 concerning novel foods and novel food ingredients [1997] OJ L 43/1 ....................................................................................244–5, 252 Commission Regulation (EC) No 577/1997 of 1 April 1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products [1997] OJ L 87/3 ..................127–9 Commission Regulation (EC) No 1813/1997 of 19 September 1997 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 1979/112/EEC [1997] OJ L 257/7 ...........................252 Commission Regulation (EC) No 2181/1997 of 3 November 1997 amending Regulation (EC) No 577/1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products. [1997] OJ L 299/1.................................................129 Commission Regulation (EC) No 623/1998 of 19 March 1998 amending Regulation (EC) No 577/1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products [1998] OJ L 85/3....................................................128 Council Regulation (EC) No 1139/1998 of 26 May 1998 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 1979/112/EEC [1998] OJ L 159/4 ......................252–3 Council Regulation (EC) No. 2821/1998 of December 17 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 1970/524 concerning additives in feedingstuffs [1998] OJ L 351/4 ..............................................................................................198–9, 202 Commission Regulation (EC) No 38/1999 of 8 January 1999 supplementing the Annex to Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [1999] OJ L 5/62...............................................................................106 Commission regulation (EC) No 590/1999 of 18 March 1999 supplementing the Annex to Regulation (EC) No 1107/1996 on the registration of geographical

(A) MacMaolin Prelims

9/2/07

15:15

Page xxiv

xxiv Table of Legislation indications and designations of origin under the procedure laid down in Article 17 of Regulation (EEC) No 2081/1992 [1999] OJ L 74/8 ....................110 Commission Regulation (EC) No 872/1999 of 27 April 1999 supplementing the Annex to Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [1999] OJ L 110/4 ..........................................................................................................106 Commission Regulation (EC) No 1070/1999 of 25 May 1999 amending the Annex to Regulation (EC) No 1107/1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/1992 [1999] OJ L 130/18 ........................................................................................................111 Council Regulation (EC) No 1804/1999 of 19 July 1999 supplementing Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs to include livestock production [1999] OJ L 222/1...................................................................................222, 256, 261, 264 Commission Regulation (EC) No 49/2000 of 10 January 2000 amending Council Regulation (EC) No 1139/1998 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Council Directive 1979/112/EEC [2000] OJ L 6/13...............................253 Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms [2000] OJ L 6/15 .................................253 Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme [2000] OJ L 237/1 .................................................................................235 Commission Regulation (EC) No 2446/2000 of 6 November 2000 supplementing the Annex to Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [2000] OJ L 281/12...........................................................................106 Council Regulation (EC) No 2826/2000 of 19 December 2000 on information and promotion actions for agricultural products on the internal market [2000] OJ L 382/2 ...................................................................276 Council Regulation (EC) No 5/2001 of 19 December 2000 amending Regulation (EEC) No 1907/1990 on certain marketing standards for eggs [2001] OJ L 2/1 ..................................................................................................267

(A) MacMaolin Prelims

9/2/07

15:15

Page xxv

Table of Legislation xxv Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs [2001] OJ L 77/1 ......................205 Commission Regulation (EC) No 1651/2001 of 14 August 2001 amending Regulation (EEC) No 1274/1991 introducing detailed rules for implementing Council Regulation (EEC) No 1907/1990 on certain marketing standards for eggs [2001] OJ L 220/5 .............................................268 Commission Regulation (EC) No 2491/2001 of 19 December 2001 amending Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [2002] OJ L 337/9......................................................256 Commission Regulation (EC) No 94/2002 of 18 January 2002 laying down detailed rules for applying Council regulation (EC) No 2826/2000 on information and promotion actions for agricultural products on the internal market [2002] OJ L 17/20 ...................................................................276 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2002] OJ L 31/1 .................................................11, 185, 187-95, 203, 208, 231, 247, 249 Commission Regulation (EC) No 1321/2002 of 22 July 2002 amending Regulation (EEC) No 1538/1991 introducing detailed rules for implementing Council Regulation (EEC) No 1906/1990 on certain marketing standards for poultrymeat [2002] OJ L 194/17..........................273–4 Commission Regulation (EC) No 1829/2002 of 14 October 2002 amending the Annex to Regulation (EC) No 1107/1996 with regard to the name ‘feta’ [2002] OJ L 277/10 .............................................................26, 111, 112, 117 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [2003] OJ L 268/1.........................................................243, 244, 247–50, 251 Regulation (EC) No 1830/2003 on the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ L 268/24..................................243, 244, 250–51 Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specific food-borne zoonotic agents [2003] OJ L 325/1 ..................................274 Commission Regulation (EC) No 2295/2003 of 23 December 2003 introducing detailed rules for implementing Council Regulation (EEC) No 1907/1990 on certain marketing standards for eggs [2003] OJ L 340/16 ....................................................................................................267–9 Commission Regulation (EC) No 185/2004 of 2 February 2004 amending Regulation (EC) No 94/2002 laying down detailed rules for applying Council Regulation (EC) No 2826/2000 on information and promotion

(A) MacMaolin Prelims

9/2/07

15:15

Page xxvi

xxvi Table of Legislation actions for agricultural products on the internal market [2004] OJ L 29/4 ............................................................................................................276 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [2004] OJ L 139/1 ..............................................................................................207–9, 221 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin [2004] OJ L 139/55.................................................................209 Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [2004] OJ L 139/206 ...................................................................209 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [2004] OJ L 165/1 ................................................10–11, 185 Commission Regulation (EC) No 1515/2004 of 26 August 2004 amending Regulation (EC) No 2295/2003 introducing detailed rules for implementing Council Regulation (EEC) No 1907/1990 on certain marketing standards for eggs [2004] OJ L 278/7 .............................................268 Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed [2006] OJ L 93/1 ......................................................................................................117–19 Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [2006] OJ L 93/12...............................5, 34, 93, 102–16, 117, 119–22, 138, 150 Commission Regulation (EC) No 699/2006 of 5 May 2006 amending Annex I to Council Regulation (EEC) No 2092/1991 as regards conditions of access for poultry to open-air runs [2006] OJ L 121/36......................264, 274 Commission Regulation (EC) No 780/2006 of 24 May 2006 amending Annex VI to Council Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [2006] OJ L 137/9 ............................255

Directives Council Directive 1964/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorised for use in foodstuffs intended for human consumption. [1964] OJ 12/161. English Special Edition Series I, Chapter 1963-1964, p.99....................4, 211–12 Council Directive 1964/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and

(A) MacMaolin Prelims

9/2/07

15:15

Page xxvii

Table of Legislation xxvii swine. [1964] OJ L 121/1977; English Special Edition Series I, Chapter 1963-1964, p.164 ...................................................................................61 Council Directive 1964/433/EEC of 26 June 1964 on health problems affecting intra-community trade in fresh meat. [1964] OJ P 121/2012. English Special Edition Series I, Chapter 1963-1964, p.185......................129–30 Council Directive 1966/402/EEC of 14 June 1966 on the marketing of cereal seed. [1966] OJ 125/2309. English Special Edition Series I, Chapter 1965-1966, p.143 .....................................................................................4 Commission Directive 1970/50/EEC of 22 December 1969 based on the provisions of Article 33(7), on the abolition of measures which have an effect equivalent to quantitative restrictions on imports and are not covered by other provisions adopted in pursuance of the EEC Treaty. [1970] OJ L 13/29. [1970] OJ English Special Edition Series I, Chapter 1970(1), p.17....................................................................................19–22 Council Directive 1970/357/EEC of 13 July 1970 on the approximation of the laws of the Member States concerning the antioxidants authorised for use in foodstuffs intended for human consumption [1970] OJ L 157/31 ........................................................................................................213 Council Directive 1970/524 of 23 November 1970 concerning additives in feedingstuffs [1970] OJ L 270/1....................................................................202 Council Directive 1971/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat. [1971] OJ L 55/23; [1971] English Special Edition Series I, Chapter 1971(1), p.106................................................61 Council Directive 1973/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption [1973] OJ L 228/23...........4, 7–10, 70, 93, 94 Council Directive 1974/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs [1974] O J L 189/1 ....214–15 Council Directive 1974/409/EEC of 22 July 1974 on the harmonisation of the laws of the Member States relating to honey [1974] OJ L 221/10...................................................................................4, 70, 93, 99, 100 Council Directive 1975/726/EEC of 17 November 1975 on the approximation of the laws of the Member States concerning fruit juices and certain similar products [1975] OJ L 311/40 ..............................93, 97 Council Directive 1976/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products [1976] OJ L 46/1 .....................88–9 Council Directive 1976/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs [1976] OJ L 340/19 ...............203 Council Directive 1977/436/EEC of 27 June 1977 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts [1977] OJ L 172/20...........................................................................93, 96

(A) MacMaolin Prelims

9/2/07

15:15

Page xxviii

xxviii Table of Legislation Council Directive 1979/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer [1979] OJ L 33/1.......................................................35, 42, 72, 78–9, 90, 253, 270 Council Directive 1979/693/EEC of 24 July 1979 on the approximation of the laws of the Member States relating to fruit jams, jellies and marmalades and chestnut purée [1979] OJ L 205/5 ..............................4, 93, 102 Council Directive 1976/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs [1976] OJ L 340/19...............................203 Council Directive 1980/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 1971/354/EEC [1980] OJ L 39/40 ........................87–8 Council Directive 1980/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters [1980] OJ L 229/1 ...............................................123–6 Council Directive 1981/389/EEC of 12 May 1981 establishing measures necessary for the implementation of Directive 1977/489/EEC on the protection of animals during international transport [1981] OJ L 150/1 ............................................................................................................62 Council Directive 1982/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs [1982] OJ L 297/26 ........................................................................................................204 Council Directive 1983/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations [1983] OJ L 109/8.............................................................................69 Council Directive 1984/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising [1984] OJ L 250/17 ........................................................................................123, 228, 270 Council Directive 1984/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs [1984] OJ L 277/12...............................204 Council Directive 1988/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients, hexane may be used in the production of cocoa butter [1988] OJ L 157/28............................95, 96–7 Council Directive 1988/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production [1988] OJ L 184/61 ................................................................................................218, 244 Council Directive 1989/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised

(A) MacMaolin Prelims

9/2/07

15:15

Page xxix

Table of Legislation xxix for use in foodstuffs intended for human consumption [1989] OJ L 40/27 ................................................................................5, 215–16, 217, 244 Council Directive 1989/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs [1989] OJ L 40/38 .............203–5 Council Directive 1989/344/EEC of 3 May 1989 amending, for the ninth time, Directive 1973/241/EEC on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption [1989] OJ L 142/19 .........................................................................8 Council Directive 1989/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products [1989] OJ L 212/87 ........................................................................271–3 Council Directive 1989/617/EEC of 27 November 1989 amending Directive 1980/181/EEC on the approximation of the laws of the Member States relating to units of measurement [1989] OJ L 357/28.......................................88 Council Directive 1990/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms [1990] OJ L 117/1 ..................243–4, 251 Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms [1990] OJ L 117/15 ................................................................243–4, 246–7, 251, 254, 260 Council Directive 1990/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs [1990] OJ L 276/40 ..............73, 97–8, 225-6, 228–9, 233 Council Directive 1991/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves [1991] OJ L 340/28 ............................................................................................259, 265–6 Council Directive 1991/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs [1991] OJ L 340/33 ........................................................................................259, 266, 267 Council Directive 1992/115/EEC of 17 December 1992 amending for the first time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients [1992] OJ L 409/31 .........................................97 Commission Directive 1993/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs [1993] OJ L 93/27 .......................................................204 Council Directive 1993/43/EEC of 14 June 1993 on the hygiene of foodstuffs [1993] OJ L 175/1 ........................................................................................209–10 Council Directive 1993/77/EEC of 21 September 1993 relating to fruit juices and certain similar products [1993] OJ L 244/23 ....................................97 Council Directive 1993/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs [1993] OJ L 290/14 ............................................................................................206 European Parliament and Council Directive 1994/35/EC of 30 June 1994 on sweeteners for use in foodstuffs [1994] OJ L 237/3....................................217

(A) MacMaolin Prelims

9/2/07

15:15

Page xxx

xxx Table of Legislation European Parliament and Council Directive 1994/36/EC of 30 June 1994 on colours for use in foodstuffs [1994] OJ L 237/13 .......................................217 Council Directive 1994/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations [1994] OJ L 368/10................................................129–30 European Parliament and Council Directive 1995/2/EC of 20 February 1995 on food additives other than colours and sweeteners [1995] OJ L 61/95.......218 Commission Directive 1996/3/Euratom, ECSC, EC of 26 January 1996 granting a derogation from certain provisions of Council Directive 1993/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea [1996] OJ L 21/42 ...........................................210 Directive 1997/4/EC of the European Parliament and of the Council of 27 January 1997 amending Directive 1979/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [1997] OJ L 43/21................................................97 Commission Directive 1997/35/EC of 18 June 1997 adapting to technical progress for the second time Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms [1997] OJ L 169/72 ............................................................................................251 Commission Directive 1998/28/EC of 29 April 1998 granting a derogation from certain provisions of Directive 1993/43/EEC on the hygiene of foodstuffs as regards the transport by sea of bulk raw sugar [1998] OJ L 140/10 ..................................................................................................209–10 Directive 1998/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations [1998] OJ L 204/37 .........236 Council Directive 1998/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes [1998] OJ L 221/23 ..................................267 Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation [1999] OJ L 6/16 ......................................................................................91, 206–7 Directive 1999/3/EC of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation [1999] OJ L 66/24 .......207 Directive 1999/4/EC of the European Parliament and of the Council of 22 February 1999 relating to coffee extracts and chicory extracts [1999] OJ L 66/26 ............................................................................................96–7 Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens [1999] OJ L 203/53.............267, 268 Directive 1999/103/EC of the European Parliament and of the Council of 24 January 2000 amending Council Directive 1980/181/EEC on the approximation of the laws of the member States relating to units of measurement [2000] OJ L 34/17.......................................................................103

(A) MacMaolin Prelims

9/2/07

15:15

Page xxxi

Table of Legislation xxxi Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [2000] OJ L 109/29...................5, 35, 72, 78–90, 97, 123, 131, 221, 227, 232, 245 Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption [2000] OJ L 197/19.........................................4, 7-10, 94–6 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and replacing Council Directive 1990/220/EEC [2001] OJ L 106/1......................5, 242, 244, 246–7, 249, 251, 254 Commission Directive 2001/22/EC of 8 March 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs [2001] OJ L 77/14 ..............................................................................................206 Council Directive 2001/110/EC of 20 December 2001 relating to honey [2002] OJ L 10/47 ....................................................................................4, 99–101 Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption [2002] OJ L 10/58 ............................................................................................97–8 Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption [2002] OJ L 10/67 ..................................................4, 101–2 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements [2002] OJ L 183/51 .......................................232–3 Commission Directive 2003/40/EC of 16 May 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters [2003] OJ L 126/34 ........................................................................................125–6

Decisions Commission Decision 1993/53/EEC of 21 December 1992 setting up a scientific committee for designations of origin, geographical indications and certificates of specific character [1993] OJ L 13/16 ..................................109 Commission Decision 1994/474/EC of 27 July 1994 concerning certain protection measures relating to bovine spongiform encephalopathy and repealing Decisions 1989/469/EEC and 1990/200/EEC [1994] OJ L 194/96 ........................................................................................................179 Commission Decision 1996/281/EC of 3 April 1996 concerning the placing on the market of genetically modified soya beans (Glycine max L.) with

(A) MacMaolin Prelims

9/2/07

15:15

Page xxxii

xxxii Table of Legislation increased tolerance to the herbicide glyphosate, pursuant to Council Directive 1990/220/EEC [1996] OJ L 107/10 ...................................................252 Commission Decision 1997/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 1990/220/EEC [1997] OJ L 31/69 .....................................................252 Commission Decision 1997/579 setting up scientific committees in the field of consumer health and food safety [1997] OJ L 237/18.................................202 Commission Decision 1998/613/EC of 21 October 1998 concerning a draft Decree of the Republic of Austria on the identification of genetically modified additives and flavourings used as food ingredients [1998] OJ L 291/35 ........................................................................................................253 Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [1999] OJ L 184/23 ................................................................184, 193–4, 231, 233

Recommendations Commission Recommendation 1980/1089/EEC of 11 November 1980 addressed to the Member States concerning tests relating to the safety evaluation of food additives [1980] OJ L 320/36 .............................................214 Commission Recommendation 2003/556/EC of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming [2003] OJ L 189/36 ..............................................................................262

INTERNATIONAL General Agreement on Tariffs and Trade, 1947 and 1994...........................133, 139 Agreement Establishing the World Trade Organisation .....................134, 135, 146 WTO Agreement on Sanitary and Phytosanitary Measures...................................................................14, 15, 133, 134, 138–42, 150 WTO Agreement on Technical Barriers to Trade..............14, 133, 135, 142–4, 151 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights................................................................................................14, 133, 134–8 WTO Agreement on Agriculture ......................................................133, 135, 144–5 WTO Agreement on Subsidies and Countervailing Measures............................135 Codex Alimentarius recommended International Code of Practice, General principles of Food Hygiene 1/1969; revised 2003 ......................156, 208

(A) MacMaolin Prelims

9/2/07

15:15

Page xxxiii

Table of Legislation xxxiii Codex Alimentarius General Guidelines on Claims, Codex Guidelines 1/1979; revised 1991 ..................................................................158, 164, 166, 227 Codex Alimentarius Code of Ethics for International Trade in Food, 1979; revised 1985..........................................................................................156–8 Codex Alimentarius Standard for Honey, Codex Standard 12/1981; revised 1987 and 2001 ......................................................................................101 Codex Alimentarius Standard for Cocoa Butter, Codex Standard 86/1981; revised 2001 ..................................................................................170–71 Codex Alimentarius Standard for Chocolate, Codex Standard 87/1981; revised 2003................................................................................................158, 170 Codex Alimentarius Standard for Cocoa Powders (Cocoas) and Dry Mixtures of Cocoa and Sugars, Codex Standard 105/1981; revised 2001 ......171 Codex Alimentarius Standard for the Labelling of Prepackaged Foods, Codex Standard 1/1985; revised 1991 and 2005 ........................156, 158–62, 168 Codex Alimentarius Guidelines on Nutrition Labelling, Codex Guidelines 2/1985; revised 1993 and 2003 ...................................156, 158, 162–7 Codex Alimentarius Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Use, Codex Standard 146/1985 ..............................164 Codex Alimentarius Standard for Cocoa Butter Confectionery, Codex Standard 147/1985 .................................................................................171 Codex Alimentarius General Principles for the Addition of Essential Nutrients to Foods, Codex Guidelines 9/1987; revised 1991 ..........................166 Codex Alimentarius Standard for the Labelling of and Claims for Foods for Special Medical Purposes, Codex Standard 180/1991 ...............................165 Codex Alimentarius Principles for Food Import and Export Certification and Inspection, Codex Guidelines 20/1995......................................................170 Codex Alimentarius Guidelines for Use of Nutrition and Health Claims, Codex Guidelines 23/1997; revised 2004..........................................158, 227, 229 Codex Alimentarius Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods, Codex Guidelines 32/1999; revised 2001 and 2004 ..........................................................158, 167–70 Codex Alimentarius Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems, Codex Guidelines 53/2003 ...................................................................63 Codex Alimentarius Standard for Canned Bamboo Shoots, Codex Standard 241/2003 .............................................................................................................151 Codex Alimentarius Standard for Fermented Milks, Codex Standard 243/2003 ...................................................................................................42, 171–2 Codex Alimentarius Standard for Oranges, Codex Standard 245/2004 .............151 Codex Alimentarius Standard for Fruit Juices and Nectars, Codex Standard 247/2005 .............................................................................................151 Codex Alimentarius Advisory Specifications for Food Additives, 12/2006 ...............................................................................................................218

(A) MacMaolin Prelims

9/2/07

15:15

Page xxxiv

xxxiv Table of Legislation Paris Convention for the Protection of Industrial Property 1883-1967 (Stockholm Act).................................................................................................136 International Convention on the Use of Appellations of Origin and Denominations of Cheeses 1951 (Stresa Convention) ....................................119 International Plant Protection Convention 1951 ................................................139 Vienna Convention on Ozone Depleting Substances 1985.................................196 Convention on Biological Diversity Cartagena Protocol on Biosafety 2000 ................................................................................................246–7 International Dairy Agreement 1980....................................................................135 International Bovine Meat Agreement 1980 ........................................................135 International Cocoa Agreement 2001.................................................................9–10

UNITED KINGDOM Assize of Bread and Ale 1266.....................................................................................3 Adulteration of Tea and Coffee Act 1724 .................................................................3 Adulteration of Tea Act 1730 ....................................................................................3 Adulteration of Tea Act 1776 ....................................................................................3 Bread Act 1822 ...........................................................................................................3 Corn, Peas, Beans or Parsnips and Cocoa Act 1822.................................................3 Bread Act 1836 ...........................................................................................................3 Adulteration of Food or Drink Act 1860 ..................................................................3 Food and Drugs (Adulteration) Act 1928 ................................................................3 Specified Bovine Offal Order 1995, SI 1928/1995................................................178 Specified Bovine Offal (Amendment) Order 1995, SI 3246/1995.......................178

(B) MacMaolin Ch1

9/2/07

15:15

Page 1

1 Regulating the Food Industry 1.1 INTRODUCTION

F

OOD SAFETY IS an issue of major concern throughout Europe. Much of this anxiety results from a series of well publicised recent health scares. From the mid-1980s onwards, listeria in cheese, salmonella in eggs and chocolate, bovine spongiform encephalopathy in beef, genetically modified vegetables and soya, the use of hormones in meat production, toxins, foot and mouth, avian influenza and e-coli have all, at one time or another, given rise to particular cause for concern. It has become clear, in the aftermath of many of these alarms, that the law is generally ill equipped to respond to new crises as and when they arise, often resulting in legally questionable emergency measures being taken. In addition to these safety issues, other important matters relating to the production and marketing of food have also surfaced in recent years. For example, the promotion of free movement for goods throughout the 25 Member States of the European Union (EU) has been coupled with concerns about depreciating food quality levels, brought about by the high degree of protection accorded to the principle of mutual recognition. This requires that once a food product is lawfully marketable in any one Member State it must, subject to limited exceptions, be lawfully marketable in all. Furthermore, where the Community has set harmonised standards for generic foodstuffs, these have tended to be set at the lowest common level.1 Traditional, locally and regionally produced products that have sustained communities for generations now come under threat from mass produced and nutritionally inferior substitutes, manufactured from poor quality ingredients by different methods of production. The resulting products, though qualitatively inferior, are legally marketable under the same food name. It is often very difficult for either national governments or the EU institutions to take action to counteract this without contravening current Community law and policy. The structure of the law and policy of the European Union directly favours certain practices which devalue the quality of food. Manufacturers and producers are agile and adept at putting pressure on local and European politicians to maintain outdated and unsustainable systems of production preventing improvements in food quality. Producers are even financially rewarded for the non-production 1 For further discussion on how harmonising rules can be used to protect consumers see S Weatherill, EU Consumer Law and Policy (Cheltenham, Edward Elgar, 2005).

(B) MacMaolin Ch1

9/2/07

15:15

Page 2

2 Regulating the Food Industry of goods. Though the common market is based upon the concept of the free movement of goods and services within the EU, the other side of the same coin is to effectively ban the importation of goods from outside the Member States, even where these goods are of equal or superior quality or cheaper in price. This effectively deprives consumers of choice. It is no surprise that the resulting food production system is no longer acceptable, since not only does it result in decreased efficiency of production, lower quality of goods and increased wastage of food; it also has an injurious effect on the economic growth of countries outside the Union, that younger electorates no longer consider politically acceptable. Globalised rules on technical barriers to trade, sanitary and phytosanitary measures and trade-related aspects of intellectual property rights all have the potential to render EU food laws contrary to international commitments. Measures introduced to protect human health or the environment must be scientifically justifiable to be capable of withstanding World Trade Organization (WTO) scrutiny. This can bring EU legislators into direct conflict with consumer groups who seek to minimise the negative impacts of the ever-increasing use of technology and innovation in food production. Animal welfare, human nutrition and human rights considerations also have an important, yet much underused, role to play in shaping EU food law. In particular, the Community legislator has tended to overlook the need to ensure that the food that is produced and consumed continues to serve its primary function of providing nutrition and sustenance. Politicians have allowed the fundamental Community principle of the free movement of goods to underlie all key harmonising provisions in this area at the expense of health and consumer protection. Emphasis on safety in the aftermath of the ‘food scares’ has also resulted in the quality and nutritional value of food receiving less attention in new legislative initiatives. It is here contended that the future of EU food law lies not with the preoccupation with ensuring that food is safe, or at least that the possibility of ‘unsafe’ food entering the chain is minimised. Instead, attention now needs to be shifted onto a group of key factors, including production efficiency, nutritional value, quality levels, ethical considerations, consumer protection and human health protection which, when combined, should result in the creation of a more unified and simplified body of rules that leaves more autonomy with the individual Member State in deciding what the consumer should be encouraged to eat, and what the consumer should probably be protected from. 1.2 HISTORICAL DEVELOPMENT OF FOOD LAW

The need for laws regulating the production and marketing of food has long been obvious. This is evidenced from some of the earliest historical writings which indicate the existence of codifying rules designed to protect consumers from dishonest practice in the sale of food.2 Assyrian tablets described the methods to 2 See FAO and WHO, ‘Origins of the Codex Alimentarius’ in Understanding the Codex Alimentarius (1999), ISBN 92-5-104248-9.

(B) MacMaolin Ch1

9/2/07

15:15

Page 3

1.2 Historical Development of Food Law 3 be used to determine the correct weights and measures for grain; Egyptian scrolls prescribed the labelling to be applied to certain foodstuffs; in ancient Athens, beer and wine were inspected for purity and soundness; the Romans had a highly organised state food control system to protect consumers from fraud or poor produce.3 Ancient Irish laws (Bechbretha) legislated for, inter alia, the resolving of disputes over the ownership of fruit that fell on a neighbour’s land. If a tree growing on A’s land drops fruit onto that of B, this is to be divided between A and B for three years. In year four, it all goes to B. The cycle restarts in year five.4 In Europe during the middle ages individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine and bread.5 The famous German beer-purity laws (Biersteuergesetz) were introduced in 1516.6 In France, systemised wine quality classification laws (Appelation d’Origine Controlée) were first introduced in 1935. In the United Kingdom, laws relating to food developed from the medieval guilds, which sought to maintain the purity of the commodities in which their members dealt, resulting in, for example, the Assize of Bread and Ale 1266.7 Early statutes tended to deal with specific foodstuffs rather than general principles of food law. These included the Adulteration of Tea and Coffee Act 1724, the Adulteration of Tea Act 1730, which prohibited the use of sloe leaves, liquorice leaves and already used tea leaves in tea, the Adulteration of Tea Act 1776, the Bread Acts 1822 and 1836, and the Corn, Peas, Beans or Parsnips and Cocoa Act 1822, which established a licensing system for the sale of these foodstuffs. Most of this legislation tended to be introduced for three main reasons: to protect human health; to promote fair trade; and to protect State revenues gained from trade in pure forms of the foodstuffs. The first UK Act of Parliament to deal with the sale of food more generally was the Adulteration of Food or Drink Act 1860, which made it an offence to knowingly sell food containing any injurious ingredient or which was adulterated in any way.8 More ad hoc legislation was introduced later, dealing with the composition and labelling of margarine, milk, butter, dairy products, preservative use and the labelling of imported meat.9 Existing food laws were later consolidated in the Food and Drugs (Adulteration) Act 1928. During the second half of the 19th century, more general food laws began to appear throughout Europe, establishing more formalised food control systems 3

Ibid. F Kelly, A Guide to Early Irish Law (Dublin, Dublin Institute for Advanced Studies, 1988). 5 FAO and WHO, Understanding the Codex Alimentarius, note 2 above. 6 These rules, which had persisted for nearly 500 years, were the subject of examination for compatibility with EU rules on the free movement of goods in Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. See Chapter 2 below. 7 51 Hen 3 Stat 1. 8 Article 1. The Act also contained provisions on food analysis (Arts 3, 4 and 5) and rights of appeal (Arts 6, 7 and 9), and established a legal definition of ‘food and drink’ for the first time (Art 14) as including ‘not only all alimentary substances, whether solids or liquids, but also all eatables or drinkables whatsoever not being medical drugs or articles usually taken or sold as medicines’. 9 For further details, see Halsbury’s Laws of Englanwd 4th edn (London, LexisNexis, 2000). 4

(B) MacMaolin Ch1

9/2/07

15:15

Page 4

4 Regulating the Food Industry and compliance monitoring procedures. Around the same time, food chemistry and science brought about changes to the manner in which food was to be produced. Methods were devised to establish the purity of food. Harmful industrial chemicals were often used to disguise the true colour or nature of food. Science could now provide the methods and processes by which these, and other, practices could be readily identified and to enable distinctions to be made between safe and unsafe food. The preponderance of food laws in the Member States comes directly from the EU since their accession to the EC Treaties. Food Laws come either in the form of new requirements introduced by way of regulation or directive, or by way of alterations that must be made to domestic law following decisions of the Community courts. The EU institutions commenced their harmonisation programme for food laws at a very early stage in the development of the Community legal order. Initial examples of this activity through legislative means can be seen in Council Directive 1964/54 on preservative use,10 Council Directive 1966/402 on the marketing of cereal seed, which sought to ensure that the quality of seeds used in cereal production were of a set minimum quality standard,11 and the original ‘recipe laws’. The ‘recipe laws’ set common compositional and production method requirements for, amongst others, chocolate,12 honey,13 and jams and marmalades.14 Initial case law on the free movement of goods was also to have a substantial impact on the food laws of the individual Member States. Cases such as Cassis15 and Commission v Germany 16 were to lead to an alteration in domestic customary practices and rules for the production and marketing of food and drink, often nullifying the effectiveness of national laws that had remained relatively unchanged for centuries. It was also clear, from subsequent decisions of the European Court of Justice, that the legal principles developed from these initial judgments would extend to all national rules relating to food and drink that were deemed to be a restriction on trade within the Community in any way, subject to

10 Council Directive 1964/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorised for use in foodstuffs intended for human consumption. [1964] OJ 12/161. English Special Edition Series I, Chapter 1963–4, p 99. 11 Council Directive 1966/402/EEC of 14 June 1966 on the marketing of cereal seed. [1966] OJ 125/2309. English Special Edition Series I, Chapter 1965–6, p 143. 12 Council Directive 1973/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption. [1973] OJ L 228/23. Now replaced by Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption. [2000] OJ L 197/19. 13 Council Directive 1974/409/EEC of 22 July 1974 on the harmonisation of the laws of the Member States relating to honey. [1974] OJ L 221/10. Now replaced by Council Directive 2001/110/EC of 20 December 2001 relating to honey. [2002] OJ L 10/47. 14 Council Directive 1979/693/EEC of 24 July 1979 on the approximation of the laws of the Member States relating to fruit jams, jellies and marmalades and chestnut purée. [1979] OJ L 205/5. Now replaced by Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption. [2002] OJ L 10/67. 15 Case 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649. 16 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227.

(B) MacMaolin Ch1

9/2/07

15:15

Page 5

1.3 Importance of the Food Sector in the EU 5 some, albeit very limited, exceptions.17 The manner in which the Court began to interpret the EC Treaty, in particular Articles 28 to 30 thereof,18 according to the Commission, removed much of the need to introduce further harmonising measures, such as those set out in the earlier recipe laws.19 However, secondary Community legislation would still be required for many aspects of the food production and marketing process. This body of legislation now extends to cover matters such as food labelling,20 additive use,21 protected geographical food names,22 organic food production,23 the deliberate release of genetically modified organisms,24 and, probably, nutrition and health claims.25 As new technologies are applied to the production of food, new laws are required to control their use, and to appease consumers’ uncertainty about their safety. It is generally the EU that is best placed to respond to these new requirements, given that any law that it introduces will generally become national law in all Member States simultaneously, removing the potential for anti-competitive and unfair trading practices to persist within one of the most lucrative, and probably the most important, of all the markets in the Union. At least that is the intention. 1.3 IMPORTANCE OF THE FOOD SECTOR IN THE EU

Food is of major importance to the European economy. Prior to the 2004 round of enlargement, the food and drink industry was estimated to be worth €600 billion annually, accounting for 15 per cent of total manufacturing output, involving the employment of over 2.6 million people.26 The European Union is the world’s 17 See, for example, Case 788/1979, Criminal proceedings against Gilli and Andres [1980] ECR 2071; Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839; Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019; Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489; Case 286/1986, Ministère public v Gérard Deserbais [1988] ECR 4907; Case 274/1987, Commission v Germany (meat products) [1989] ECR 229; Case 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021; Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 18 Formerly Arts 30–36 EC. 19 Communication on the free movement of foodstuffs within the Community. [1989] OJ C 271/3. 20 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 21 Council Directive 1989/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. [1989] OJ L 40/27. 22 Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [2006] OJ L 93/12. 23 Council Regulation (EEC) No 2092/1991 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [1991] OJ L 198/1. 24 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and replacing Council Directive 1990/220/EEC. [2001] OJ L 106/1. 25 Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods. COM (2003) 424. 26 Figures taken from Chapter 1 of the European Commission White Paper on Food Safety. COM (1999) 719.

(B) MacMaolin Ch1

9/2/07

15:15

Page 6

6 Regulating the Food Industry largest producer of food and drink products. In addition to this, agriculture was worth €220 billion per year, including €50 billion in exports to third countries, providing 7.5 million full-time jobs. More recent figures suggest that turnover in the food and drinks industry, post-enlargement to 25 Member States, had risen to €799 billion, involving the employment of 4.1 million people. Meat processing alone accounts for €161 billion turnover in the EU, €31 billion of which is profit. In fact, meat processing has become an even more lucrative industry in recent years, despite the identified decline in consumer confidence levels after the BSE (Bovine Spongiform Encephalopathy), foot and mouth and avian flu scares. Annual turnover in the dairy sector in the EU stands at €117 billion, €18 billion of which is profit. Beverages turnover is €118 billion, generating €31 billion profit in 2005.27 Total exports of food and drink from the EU in 2003 were worth €44.5 billion, with imports from third countries into the Community standing at €38.7 billion, leaving a trade surplus in the EU for food and drink of nearly €6 billion, with the United States being the main export destination for European Union foodstuffs. Of the top 10 food exporters in the world, seven (France, Netherlands, Germany, Belgium, Spain, UK and Italy) are EU Member States, all of which are currently larger exporters of food than China.28 Overall, the food and drinks industry is the largest manufacturing sector in the EU, accounting for almost 15 per cent of the sector. Trade in food is a major political issue. EU Member States seek to preserve the customary method of manufacture for their traditional and national foodstuffs. National laws often reflect the preferences of consumers in each of the Member States. This, however, tends to fall foul of Community law obligations in one of two ways. Either these national rules inhibit the free movement of food in the Community by making it more difficult for producers in other Member States manufacturing the same or similar products to gain access to the domestic market of the host State contrary to Article 28 EC prohibiting quantitative restrictions on trade or measures of equivalent effect. Alternatively, no Member State can maintain national laws that are out of line with the harmonised EU standard introduced by way of secondary Community legislation. In relation to the former, Member States can plead various justifications for the existence of these trade-inhibiting rules before the Community Courts. This is discussed in more detail in Chapter 2. On the latter, much political wrangling may surround the common standard that is to be, or which has been, adopted. Each Member State, or group of Member States, seeks to have the approximated compositional requirement and/or method of production as close to its existing standard as possible. The obvious advantage of this is that the less domestic producers have to modify their own method of production, the more the harmonised Community standard approximates to their existing practices. An example of the duration and intensity of the debate that can surround the introduction of these standardised Community rules was most famously seen in relation to the chocolate directive. 27

USDA Foreign Agricultural Service GAIN Report E35067, The EU’s Food and Drink Industry

2005. 28

WTO, International Trade Statistics, ISBN 9287012202.

(B) MacMaolin Ch1

9/2/07

15:15

Page 7

1.3 Importance of the Food Sector in the EU 7 1.3.1 Chocolate Debate The original directive setting out the compositional requirements entitling producers to use one of the variety of legal names available for different types of chocolate was finally replaced after much expense and debate in 2000.29 ‘Chocolate’ was defined in Annex I to the original chocolate directive as: The product obtained from cocoa nib, cocoa mass, cocoa powder or fat-reduced cocoa powder and sucrose with or without added cocoa butter, having . . . a minimum total dry cocoa solids content of 35%—at least 14% of dry non-fat cocoa solids and 18% of cocoa butter.

It is similarly, if slightly more simply, defined in the 2000 directive.30 The original directive also set out the compositional requirements for legitimate use of the legal names ‘plain chocolate’, ‘milk chocolate’, and ‘milk chocolate with high milk content’.31 Whilst chocolate had to contain a minimum of 35 per cent cocoa, milk chocolate with high milk content was only required to contain 20 per cent cocoa. The United Kingdom and Ireland, along with Denmark, were about to become Member States of what was then called the European Economic Community. Chocolate produced in the United Kingdom and Ireland was traditionally manufactured using 20 per cent cocoa solids and 20 per cent milk solids. Under the terms of the directive this chocolate would have to be marketed as ‘milk chocolate with high milk content’ in the other Member States. There milk chocolate tended to contain a minimum of 25 per cent cocoa and 14 per cent milk. Derogation was granted to the United Kingdom and Ireland from having to use this designation, claimed to be a consumer repellent, in their own territory, where it could be marketed as ‘chocolate’.32 A further difficulty existed in that British chocolate tended to be made with vegetable fats in place of cocoa butter. Many States, particularly France and Belgium, objected strongly to any derogation allowing a chocolate-type product containing vegetable fats to be legally marketable on the continent as ‘chocolate’. It was felt that only the chocolate-type product that contained no fats other than cocoa butter should be legitimately marketable as ‘chocolate’. Eight Member States had objected to the marketing of British and Irish chocolate on their territory where it contained vegetable fat: Belgium, France, Italy, Spain, Luxembourg, Germany, Greece and the Netherlands. Much political argument followed. It became apparent that the continuance of any prohibition on the sale of British chocolate on the 29 Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption. [2000] OJ L 197/19. The original Chocolate Directive was Council Directive 1973/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption. [1973] OJ L 228/23. 30 Annex I to Directive 2000/36, ibid. 31 Annex I to Directive 1973/241, note 29 above. 32 Article 3(1) of Directive 1973/241, note 29 above.

(B) MacMaolin Ch1

9/2/07

15:15

Page 8

8 Regulating the Food Industry continent under that designation could have serious consequences, both economic and political, for the free movement of goods. More specifically, it became clear that chocolate products containing fat other than cocoa butter, lawfully manufactured in a Member State, had to be permitted to circulate freely within the Community under the original sales name, provided that the products were labelled to indicate that they contained vegetable fat. The case law of the Court of Justice indicated that directives, such as that at issue here, had to be interpreted in the light of the rules of the EC Treaty, in particular those on the free movement of goods.33 As a consequence, British and Irish chocolate containing 20 per cent cocoa and up to five per cent vegetable fat would have to be legally marketable in all the Member States as ‘chocolate’. This applied even in those Member States where chocolate usually contains a minimum of 35 per cent cocoa and no fats other than cocoa butter. Some Member States continued to contravene EU law by continuing to prohibit the importation of chocolate containing vegetable fat. Italy, for example, refused to allow chocolate with a low cocoa content and containing vegetable fat to be sold there unless marketed as ‘surrogate chocolate’. A compromise deal was finally agreed upon by the Council and endorsed by the Parliament in March 2000.34 All 15 Member States, as there then were, would have to agree to allow British and Irish chocolate to be marketed on their territories, but it had to be clearly labelled as ‘family milk chocolate’ where it had a high milk content.35 Reaching this compromise was difficult. It had been complicated further by the fact that many side issues had been introduced to the debate, ranging from taste and quality to the protection of farmers in cocoa-dependent economies. Chocolate products which contain fats other than cocoa butter may now be marketed in all the Member States, provided that their labelling is supplemented by a ‘conspicuous and clearly legible statement’ that it ‘contains vegetable fats in addition to cocoa butter’; this statement to appear in the same field of vision as the list of ingredients, clearly separated from that list.36 Belgium had contested that this information should be compulsorily placed in a prominent position on the front of the label, but the European Parliament rejected this. 33 Case C-47/1990, Delhaize v Promalvin [1992] ECR I-3669 and Joined Cases C-427/1993 and C-436/1993, Bristol Myers Squibb v Paranova [1996] ECR I-3457. 34 Directive 1973/241 had been amended nine times since it was adopted, although many of the amending directives dealt with issues of minor significance only. The last of these amending directives to be introduced was Council Directive 1989/344/EEC of 3 May 1989 amending, for the ninth time, Directive 1973/241/EEC on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption. [1989] OJ L 142. This 1989 directive added to Art 14(2) of Directive 1973/241/EEC authorisation for the marketing under the name ‘chocolate familiar a la taza’ and ‘chocolate a la taza’ of chocolate containing flours and/or starches and intended for consumption with milk after cooking. 35 Annex I to Directive 2000/36/EC, note 29 above. It had been suggested at one stage in the debate that British and Irish chocolate should be labelled as ‘vegelate’ given the tendency to use vegetable fats. 36 Article 2(2). Those vegetable fats which may be added to chocolate include illipe, palm-oil, sal, shea, kokum gurgi and mango kernel. In addition to this, coconut oil may be added to chocolate used for the manufacture of ice cream and similar frozen products. Annex II to Directive 2000/36/EC, note 29 above.

(B) MacMaolin Ch1

9/2/07

15:15

Page 9

1.3 Importance of the Food Sector in the EU 9 One of the new chocolate directive’s main effects is that it permits producers to use cheaper raw materials, considered to be of lower quality than cocoa and cocoa butter, as cocoa substitutes. Almost 30 years of political wrangling ensued about the damaging effects that European Community laws on chocolate could have for both the free movement of goods and the quality of chocolate. It appeared to end in compromise, but the debate continued. It culminated in the Commission taking action against two Member States who persisted in prohibiting the marketing of chocolate from some Member States. In the cases of Commission v Spain 37 and Commission v Italy,38 the Court ruled that the two respondent Members States were in breach of their Community obligations by continuing to prohibit the marketing of products containing vegetable fats other than cocoa butter under the name ‘chocolate’. It will be remembered that products containing such fats had to be labelled in these States as ‘chocolate substitutes’. Such a policy was, according to the Commission, contrary to EC Treaty provisions designed to ensure the free movement of goods, in particular Article 28. The Member States, on the other hand, contended that their domestic legislation was necessary to protect consumers from inferior quality products. The Court found that the requirement imposed by the Member States on producers of chocolate using vegetable fats other than cocoa butter to alter their sales name to ‘chocolate substitute’ could compel traders to incur additional packaging costs while also altering consumers’ perceptions of products labelled in such a manner. The Court did accept that consumer protection was a legitimate exception to Article 28 EC, but stated that additional labelling indicating that the product was different to that which consumers would normally expect to be marketed by that name was more appropriate than a complete prohibition on the use of the name ‘chocolate’. It has also been claimed that the chocolate directive will inflict serious social and economic damage on cocoa producing countries.39 It permits the use of significantly smaller amounts of cocoa than most European consumers have become accustomed to, and allows such products to contain fats other than cocoa butter. It is possible that the amended directive is at variance with commitments undertaken by the EU Member States under the International Cocoa Agreements, in particular the undertaking to encourage increased cocoa consumption. The International Cocoa Agreement 2001,40 to which the European Union is a contracting State, clearly states that for the creation of a sustainable cocoa economy members are required to give: due consideration to the sustainable management of cocoa resources in order to provide fair economic returns to all stakeholders in the cocoa economy, bearing in mind the principles and objectives of sustainable development contained in Agenda 21, adopted 37

Case C-12/2000, Commission v Spain (chocolate) [2003] ECR I-459. Case C-14/2000, Commission v Italy (chocolate) [2003] ECR I-513. 39 See, for example, Parliamentary question P-2286/1999. [2000] OJ C 303 E. 40 International Cocoa Agreement 2001 arising out of the United Nations Cocoa Conference, Geneva, 26 February–2 March 2001. 38

(B) MacMaolin Ch1

9/2/07

15:15

Page 10

10 Regulating the Food Industry by the United Nations Conference on Environment and Development (UNCED) of 14 June 1992.41

Members must also: recognise that the use of [cocoa] substitutes may have negative effects on the expansion of cocoa consumption and the development of a sustainable cocoa economy.42

The EU is vital to the cocoa economy. Of the top eight importers of cocoa in the world, seven are Member States, the only exception in this list being the United States of America, the world’s largest importer of cocoa. Germany and the Netherlands combined account for over one quarter of total world imports of cocoa, the Member States combined accounting for well over half.43 The 30 years of debate and political wrangling that have surrounded the labelling of chocolate, and which in some ways continue to surround it, is indicative of the range of sensitivities and agendas that are all being pushed during the attempts to reach agreement on a common Community standard for food products. This makes compromise very difficult to reach. This is more so in an ever-expanding European Union of 25 or more Member States, with 25 plus sets of customs, traditions and domestic industries to be protected. There are also international obligations to be taken into account when drafting Community rules on the production and marketing of food. The EU has signed up to global agreements such as that on cocoa, or even more importantly, and with additional legal binds, the WTO Agreements. Other highly politicised food law-related issues have also arisen in recent years. The most notable of these is the posturing that surrounded the measures to be introduced when British cattle were found to be infected with BSE, a matter dealt with in more detail in Chapter 5 below. 1.3.2 Ensuring Compliance with EU Food Law Regulation 882/2004 requires Member States to maintain systems of control which ensure that food law standards are met.44 It states that food and animal feed should be safe and wholesome and that Community legislation ‘comprises a set of rules to ensure that this objective is attained’.45 This is debated throughout this book. The regulation defines ‘feed law’ as being: the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Community or national level; it covers all stages of production, processing and distribution of feed and the use of feed.46 41

Article 39(1). Article 38(1). 43 Figures taken from Annex B to the International Cocoa Agreement 2001, note 40 above. 44 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. [2004] OJ L 165/1. 45 Preamble to Regulation 882/2004. 46 Article 2. 42

(B) MacMaolin Ch1

9/2/07

15:15

Page 11

1.4 Scope of the Book 11 The regulation does not define ‘food law’. It is, however, defined in Regulation 178/2002 as: the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.47

For the purposes of this book, ‘EU food law’ includes all directives, regulations and decisions of the Community institutions and Community courts relating to the production and marketing of food and drink for human consumption. The ‘average consumer’ has been defined by the Court of Justice as being ‘reasonably well informed and reasonably observant and circumspect’,48 a phrase which will recur throughout this work.49 Regulation 882/2004 sets a series of obligations on the Member States to ensure that official controls are carried out on a regular basis,50 ‘official control’ being: any form of control that the competent authority or the Community performs for the verification of compliance with feed and food law, animal health and animal welfare rules.51

Competent authorities are: the central authority of a Member State competent for the organisation of official controls or any other authority to which that competence has been conferred.52

Member States determine who their competent authority will be.53 1.4 SCOPE OF THE BOOK

Food and the laws that regulate its production and marketing at European Union level are surrounded by a series of sensitivities and national agendas that complicate and frustrate the role of the Community institutions in their efforts to create a single market for food. It is unsurprising that Member States adopt this defensive position when the ramifications of the decisions that are made by these institutions can prove problematic for those who seek to preserve high food quality levels, good nutritional values or the preservation of traditional and customary practices. The far-reaching effects of free movement principles, in particular the 47

Article 3 thereof. See, for example, Case C-239/2002, Douwe Egberts NV v Westrom Pharma NV and Christophe Souranis [2004] ECR I-7007, para 46; Joined Cases C-421/2000, C-426/2000 and C-16/2001, Renate Sterbenz and Paul Dieter Haug [2003] ECR I-1065, para 43; and Case C-465/1998, Verein gegen Unwesen in Handel und Gewerbe Köln eV v Adolf Darbo AG [2000] ECR I-2297, para 20. 49 See further S Weatherill, ‘Consumer Policy’ in P Craig and G de Búrca, The Evolution of EU Law (Oxford, OUP, 1999), pp 699–702. 50 Article 3 thereof. 51 Article 2 of Regulation 882/2004. 52 Ibid. 53 Article 4. 48

(B) MacMaolin Ch1

9/2/07

15:15

Page 12

12 Regulating the Food Industry principle of mutual recognition of existing standards in each of the Member States, means that when the Community standardises, it must do so at the lowest common level, or at least very near to it. If Member State A insists that chocolate contain no cocoa butter, then Member States B, C and D are unlikely to be allowed to maintain their domestic provisions stipulating minimum cocoa butter levels in chocolate. If Member State E wants to prohibit or restrict the sale of foods that have a low protein and high saturated fat content, they are unlikely to be allowed to do so where Member States F, G and H have no similar provision. Consumer protection and the preservation of human health are clearly less of a priority in the EU food law harmonisation programme than the promotion of the free movement of goods and completion of the internal market. The result, as will be demonstrated throughout this book, is two sorts of situation. First, the decisions of the Court, and the subsequent conclusions drawn that harmonising standards are no longer required given the development of the mutual recognition principle, have led to a frustration and contravention of the key Treaty provisions on free movement for food. These breaches have been incurred not, as might be expected, by the Member States, but instead by the Community institutions themselves who are failing to adhere to legitimate exceptions to free movement—defining the general principle too expansively, and the exceptions to this principle far too narrowly. This has detrimental consequences for consumers in relation to their level of choice and for Member States who seek to promote healthy habits amongst their populace. Second, although the institutions have modified their behaviour somewhat in relation to human health protection in the aftermath of the BSE crisis, exceptions to the general rule on free movement and an over-emphasis on food safety, coupled with Member States’ lack of autonomy in decision-making on food-related matters, has provoked a more far-reaching ‘crisis’ within the Member States—obesity. Given the manner in which EU food law has developed thus far, these Member States are now relatively impotent when it comes to taking any meaningful action to counter obesity. Such themes are discussed in detail throughout this book. The main principles that direct EU rules on the production and marketing of food are the free movement of goods, the protection of consumers, and the preservation of human health. International obligations also present a lesser concern for the EU legislator. Through an examination of free movement case law, harmonising legislation and food safety policy, it is demonstrated that the prioritisation of free movement as the main factor in the devising, interpretation and implementation of EU food law creates a series of negative consequences for the other two main concerns. It is only through modification of this approach that these serious deficiencies can be addressed. The book commences with a detailed examination of EU rules on the free movement of food. Through an assessment of the case law on Article 28 EC, prohibiting quantitative restrictions and measures of equivalent effect, Chapter 2 shows how the Court allows certain mandatory requirements such as consumer protection and fair trading to enable Member States to deviate from these

(B) MacMaolin Ch1

9/2/07

15:15

Page 13

1.4 Scope of the Book 13 obligations in some circumstances. Article 30 EC provides Member States with the opportunity to implement measures that inhibit free movement where this is deemed necessary to protect human health. However, both operate in very limited circumstances, rendering them relatively ineffective in safeguarding Member States’ attempts to protect the health of their populace. The panacea of additional labelling disclosures, presented perennially by the Court to counter Member State representations that their contested measures or actions are proportionate and justifiable, are contradictory and over-simplistic. A reassessment is required in order to accommodate these legitimate exceptions to the general rule on free movement for food, and to protect consumers and producers from unfair trading practices. Chapter 3 examines the body of existing secondary Community legislation that is used to harmonise standards on food production and marketing in each of the Member States. In particular, it assesses the rules on food labelling, the naming of foods and the preservation of food quality. After noting how the Commission arrived at its controversial decision to cease developing harmonised vertical standards for food (those applying to specific foodstuffs only), our attention turns to the key components of the food label, as prescribed by the horizontal (applying to some aspect of the production and/or marketing of all foodstuffs) framework food labelling directive. Most aspects of this legislation are relatively straightforward, although there is still some confusion regarding the language in which labelling must appear. The name by which a foodstuff may be labelled when it moves from one Member State to another also continues to cause debate. This is primarily because each Member State has its own unique production standards in place. A Member State seeking to preserve the quality of foodstuffs traditionally produced domestically will generally be prevented from doing so due to the free movement principle. To counter depreciating food quality standards, and to preserve to some degree the divergence of foodstuffs produced within the EU, the Council has had to respond. Accordingly, it has introduced rules on food naming where there is some link between the characteristics of the product and its traditional place of production. Recent developments in the case law in this area have raised doubts about the suitability of this legislation in many situations in which it is currently applied. Redefining the limits of, and strengthening the distinctions between, the different categories of food name could remove many of the difficulties that have arisen, attributable to the manner in which the free movement of food agenda has been pursued. If successful, such a strategy would facilitate the proper protection of consumers, fair trading and the promotion of human health. The extent to which the rules governing international trade can impact on EU food laws is examined in Chapter 4. Here it is noted that the two key organisational structures have the potential to shape Community food law and policy. These are the World Trade Organization (WTO) and the Codex Alimentarius Commission, which operates under the auspices of the United Nations (UN) Food and Agriculture Organisation (FAO) and the World Health Organization (WHO). Several of the WTO Agreements can influence the manner in which the EU

(B) MacMaolin Ch1

9/2/07

15:15

Page 14

14 Regulating the Food Industry devises, interprets and implements its own rules on the production and marketing of food. For example, the existence of the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) means that the EU must undertake a scientifically sound risk assessment prior to the application of any rules that are designed to protect human health, animal health or the environment. The Agreement on Technical Barriers to Trade (TBT Agreement) obliges the EU to set its own technical standards for food in a manner that appropriately mirrors existing international standards, or those of other WTO members. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) requires that schemes designed to protect European food products with local or regional characteristics be made available to producers in third countries as well. All this means that the EU legislator must look beyond the European agenda when creating new, or applying existing, food laws. The primary reference point for assessing conformity of EU rules with international standards is the Codex Alimentarius Commission. Food safety has been pushed to the top of the EU food law agenda in recent years. The main reason for this is the furore surrounding the BSE crisis that occurred in the 1990s. The EU has had to show itself more than willing to act to safeguard human health in its aftermath. The European Food Safety Authority (EFSA) has been created to co-ordinate efforts to minimise the likelihood of other crises. Safeguard measures, notification procedures, prescribed hygienic practices and other official controls have been introduced to supplement and support the work of the Authority and the relevant Community scientific committees. However, these labours are frustrated by a failure to recognise that Member States are often best placed to act to ensure that the food that enters their marketplace is safe and wholesome. These transnational rules are based on the unsatisfactory premise that action taken at national level in this regard is contrary to Community law on the free movement of goods. While there is acceptance that precautionary measures may be introduced where evidence exists supporting such action, the circumstances in which this principle may be invoked remain unclear and ill defined. Too much emphasis has been placed on food safety in recent years, and too little on maximising its nutritional value. Chapter 6 highlights how the preoccupation with avoiding ‘food crises’ has led to insufficient action being taken to counter increasing rates of nutrition-related problems such as obesity. Most of these food crises have affected relatively few people when compared to the devastating consequences for human health that come from being either undernourished or, as tends to be the case now, overfed and obese, contributing to high levels of heart disease, cancers and strokes. EU law in this area does not extend far beyond labelling matters. Studies suggest that consumers do not really understand nutrition labelling, and generally do not read it. Member States have sought to instigate their own initiatives in this regard. However, their efforts have been frustrated by EU rules on the free movement of food. As a consequence, instead of being able to introduce a compulsory system of labelling, informing consumers in

(B) MacMaolin Ch1

9/2/07

15:15

Page 15

1.4 Scope of the Book 15 clear terms about how beneficial or detrimental a particular foodstuff may be to their health, mutual recognition limits the range of permissible options to voluntary codes of conduct. Proposed new rules on nutrition claims made for food will remove, or at least reduce, the possibility of those marketing a product making certain claims about the health benefits to be gained from consuming their food where there are also health detriments. This does not resolve the key issue here, which is the fact that Articles 28 to 30 EC and the related case law make it almost impossible for Member States to introduce measures designed to protect human health unless the foodstuff in question poses a precipitate danger to health, as opposed to merely eroding it in the longer term. New technologies or novel ways of producing food bring new difficulties for the EU lawmaker. For example, the introduction of genetically modified organisms (gmos) into the European marketplace created a plethora of problems. Consumer groups lobbied for the complete prohibition of gmos, spurred into action by disputed scientific studies which demonstrated that genetically modified food could have detrimental consequences for the intestines of rats. Rules introduced before this controversy had to be changed on numerous occasions to close loopholes and satisfy the new demands of more conscientious consumers. Ultimately, an unofficial moratorium on the approval or use of new gmos was introduced. This went some way to satisfying the concerns raised within the EU. However, it also alerted the EU’s trading partners to the fact that this was possibly in contravention of international trade law obligations, resulting in an investigation into the circumstances surrounding the introduction of this ban and its compatibility, in particular, with the WTO Agreement on Sanitary and Phytosanitary Measures. At the other end of the spectrum, organic foods and those derived from free-range animals have brought their own difficulties. Given that these types of food tend to attract a higher price on the market, these terms are open to manipulation by those who seek to gain the advantage of using them whilst paying scant attention to the criteria such goods must satisfy before any labelling claims about their ethical production can legitimately be made. This leaves the consumer in a precarious position. He or she may be paying more for a product bearing a description which does not reflect the method of its production. Generally, this book examines existing EU food laws in order to demonstrate how free movement of food obligations leave the consumer exposed to deception, the producer to unfair trading practices, and human health to the detrimental consequences of an uncoordinated food law structure that fails to adhere to Treaty obligations and Court-made exceptions to the mutual recognition principle. It suggests a three-pronged alternative approach to EU food law and policy: reconsideration of the decision taken by the Commission to cease harmonising food standards for all products; relaxation of the over-regulation of all aspects of the food production process and a resultant move towards more simple common standards; and, instead of concentrating on food safety, emphasising that food should be of high quality and beneficial to health.

(B) MacMaolin Ch1

9/2/07

15:15

Page 16

(C) MacMaolin Ch2

9/2/07

15:15

Page 17

2 Free Movement of Food in the EU 2.1 INTRODUCTION

E

UROPEAN UNION RULES on the free movement of goods impact on the food industry in many ways. The most obvious of these is the Article 28 EC prohibition on quantitative restrictions on imports and all national measures of equivalent effect. In particular, the decision of the Court of Justice in Cassis,1 and the subsequent related case law,2 established the principle that once a foodstuff is lawfully marketable in one Member State it must be lawfully marketable in all. This is so even where the importing State can demonstrate seemingly legitimate objections to the sale of a product on their territory. These might include concerns about public health, fair trading or consumer protection. The fact that two products differ in composition and/or method of production cannot generally be used by a Member State to justify national rules that require that these different products carry different names or descriptions on their labels.3 Similarly, Member States cannot prevent the marketing of foodstuffs that have a lower than usual nutritional value, or that endanger health in some way, even if they try to do so to preserve the health of their people, so long as the sale of those foodstuffs is not hindered elsewhere in the Community.4 Arguing that the nutritional needs and/or consumer preferences of a Member State justify the existence of tradeinhibiting national rules is not generally considered acceptable.5 The second key Treaty provision that is used to maximise the free movement of food is Article 90 EC. It prohibits the direct or indirect imposition in national markets of higher taxes on imported goods than on those produced domestically. This applies to comparisons between both the same and similar food products—those 1

Case 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649. For example: Case 788/1979, Criminal proceedings against Gilli and Andres [1980] ECR 2071; Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839; Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019. 3 For example: Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489; Case 286/1986, Ministère public v Gérard Deserbais [1988] ECR 4907. 4 See, for example, Case 274/1987, Commission v Germany (meat products) [1989] ECR 229; Case 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021; Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 5 See, in particular, Case 178/1984, Commission v Germany (bier) [1987] ECR 1227; Case 274/1987 Commission v Germany (meat products) [1989] ECR 229; Case C-41/2002 Commission v Netherlands (fortified foods). 2

(C) MacMaolin Ch2

9/2/07

15:15

Page 18

18 Free Movement of Food in the EU that may be deemed to be in at least partial competition in the same market may be compared for Article 90 EC purposes. The Court of Justice has assisted in maximising the positive effects of this by defining ‘markets’ expansively. This has reduced the possibilities for Member States to indirectly protect their own goods from similar type imports.6 This could have presented benefits for the domestic consumer and the Community producer alike, but the actual effects remain limited, stifled by the political sensitivities of EU interference with national taxation regimes. As a consequence, the potential profits that could arise from full application of Article 90 EC are far outweighed by the negative effects of Article 28 EC for the protection of consumers. The full benefits of overall free movement policy are, as yet, unfulfilled. Third, the Article 25 EC prohibition on charging customs duties and charges of equivalent effect presents a difficulty for a national authority that seeks to reduce health risks from imported foodstuffs. Court interpretation of this ban has established that expenses incurred by an importing Member State in inspecting the safety of goods entering their territory may not be passed on to the exporter,7 subject to some well-defined exceptions.8 Such an authority consequently faces a dilemma: inspect, and absorb the costs, or avoid incurring these costs by relying on inspections, if there have been any, that have taken place in the exporting State. This Court-created predicament is seemingly at odds with the Community emphasis on creating and maintaining the safest possible system for the distribution of foodstuffs.9 Finally, it should be noted at this stage that, despite the preponderance of case law and academic literature pertaining to Articles 25, 28 and 90 EC, it is in fact the much-overlooked European Community harmonisation programme that has the potential to cause the greatest upheaval for the food industry, and for its producers, consumers and the Member States alike. It is often the minutiae of secondary legislation rather than the sweeping and all-encompassing Treaty-enshrined principles that engenders controversy about how the Community behaves in relation to food. Hygiene rules, labelling laws and compositional requirements can all have a significant economic impact on the producer and, consequently, the consumer as well. Consider, for example, the new rules on health and nutrition claims.10 While obliging producers to substantiate claims of this nature is a welcome move, there can be no doubt about the potentially devastating outcome of this for small businesses, which now have to invest large proportions of their available resources into producing the required scientific demonstration to legitimise statements made regarding the beneficial properties of their goods. Similarly, European 6

Case 170/1978, Commission v UK (wine and beer tax) [1983] ECR 2265. Case 87/1975, Conceria Daniele Bresciani v Amministrazione Italiana delle Finanze [1976] ECR 129; Case 314/1982, Commission v Belgium (imported poultry meat) [1984] ECR 1543. 8 See, in particular, Case 46/1976, Bauhuis v Netherlands [1977] ECR 5. 9 In particular that arising out of the Commission White Paper on Food Safety. COM (1999) 719. 10 Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods. COM (2003) 424. Discussed in more detail in Chapter 6 below. 7

(C) MacMaolin Ch2

9/2/07

15:15

Page 19

2.2 Measures Equivalent to Quantative Restrictions 19 Union rules on hygienic food production render the production of traditional local foodstuffs, such as certain types of cheese, difficult or impossible. By setting strict generic requirements, applicable to the multinational oligopolist and the small-scale producer alike, many EU rules on production methods have rendered it near impossible for foodstuffs that have been produced using traditional methods for supply to local markets to continue legally.11 Such drastic consequences arise from measures often taken in the name of human health protection. Their effect has been to terminate the production of foodstuffs that have been produced and consumed for generations with no obvious ill effects on anybody’s health. It is a combination of the disproportionate and inflexible nature of the EU institutions’ responses to so-called ‘food crises’, along with the tendency to promote free movement above all other considerations, that has the potential to destroy the rich culinary diversity of the Member States. Intensive farming methods have contributed to many of these ‘emergencies’. Consumer confidence in the safety and wholesomeness of food will be best restored by reverting to local production through non-intensive methods.12 This requires proper EU institutional support, and it can only happen when there is acceptance that the citizens of Europe share some similarities but are also hugely different in many ways— with differing tastes, preferences and needs. It must be recognised that the same ‘average consumer’ does not exist in 25 different States. The harmonisation of habits, tastes and nutritional requirements will never come about, despite the best efforts of the Community institutions to achieve this in the quest for absolute free movement. In the meantime, and until this realisation is accepted, food quality, safety and nutritional value will continue to suffer as a result. 2.2 MEASURES EQUIVALENT TO QUANTITATIVE RESTRICTIONS ON THE FREE MOVEMENT OF FOOD

Article 28 EC (formerly Article 30 EC) sets out the general obligation on Member States to ensure that ‘quantitative restrictions on imports and all measures having equivalent effect shall . . . be prohibited between Member States’. This wide-ranging responsibility received further elaboration and clarification in Commission Directive 1970/50.13 The preamble to the directive states that the abolition of measures equivalent to quantitative restrictions on imports is necessary as otherwise 11 For further discussion see D Chalmers, ‘Food for Thought: Reconciling European Risks and Traditional Ways of Life’ (2003) 66 Modern Law Review 532, in particular 544–7. 12 For further discussion on the effects on food quality, human health and the environment of modern methods of food production see P Singer and J Mason, The Way We Eat: Why Our Food Choices Matter (Emmaus, PA, Rodale, 2006); J Humphrys, The Great Food Gamble (Philadelphia, PA, Coronet Books, 2001). 13 Commission Directive 1970/50/EEC of 22 December 1969 based on the provisions of Article 33(7), on the abolition of measures which have an effect equivalent to quantitative restrictions on imports and are not covered by other provisions adopted in pursuance of the EEC Treaty. [1970] OJ L 13/29; [1970] English Special Edition Series I, Chapter 1970(1), p 17. It has been stated of Article 28 EC that it ‘is striking for its brevity’. See S Weatherill and P Beaumont, EC Law 3rd edn (Harmondsworth, Penguin Books, 1999).

(C) MacMaolin Ch2

9/2/07

15:15

Page 20

20 Free Movement of Food in the EU the customs union would not be possible. To facilitate this, the ambit of the directive covers measures that obstruct the importation of products from other Member States in any way, either by preventing their importation completely or by hindering their access to the market by insisting that certain conditions be fulfilled beforehand.14 This has come to mean that: (i) any measure that makes it more inconvenient for the seller to market their product in the territory of a Member State other than their own, which cannot be justified under one of the exceptions to this rule (rule of reason or mandatory requirement, dealt with in detail throughout this chapter), or which is not a ‘selling arrangement’ as defined by the Court of Justice in Keck and later clarified by its related case law;15 or (ii) any similar measure which makes it more difficult for the seller to market their product in their own State, especially if other markets in the EU are more readily accessible, is considered to be an unlawful measure. Directive 1970/50 does state that, in particular, requirements subjecting imported products to a condition with which domestic products were not also obliged to comply, or with which they could comply more readily, are regarded as being measures equivalent to quantitative restrictions on imports.16 This now, however, also clearly includes marketing conditions (subject of course to exceptions) which domestic producers have to comply with, which they may not face when marketing the same product elsewhere in the Union. The most important aspect of the directive is that it sets out a list of those measures which, unless justifiable, are likely to constitute an unlawful restriction on the free movement of goods. Out of a list of 19 such examples, only three had, and continue to have, any real impact on the case law and legislation supporting the free movement of food, and arguably of goods in general. These are: (i) compositional requirements and product specifications; (ii) product names not related to origin; and (iii) controls, other than those inherent in the customs clearance procedure, which are more strict than those applied to domestic products where this is not necessary to ensure equivalent protection.17

2.2.1 Dassonville and Directive 1970/50 Some of the most significant case law in the Article 28 EC jurisprudence relates specifically to the free movement of foodstuffs. Dassonville, which concerned 14

Article 2(1). Joined Cases C-267/1991 and C-268/1991, Criminal proceedings against Keck and Mithouard [1993] ECR I–6097, as further clarified in particular by Joined Cases C-69/1993 and C-258/1993, Punto casa SpA v Sindaco del Comune di Capena et Comune di Capena and Promozioni Polivalenti Venete Soc coop arl (PPV) v Sindaco del Comune di Torri di Quartesolo and Comune di Torri di Quartesolo [1994] ECR I-2355; Case C-368/1995, Vereinigte Familiapress Zeitungsverlags- und vertriebs GmbH v Heinrich Bauer Verlag [1997] ECR I-3689; Joined Cases C-34/1995, C-35/1995 and C-36/1995, Konsumentombudsmannen (KO) v De Agostini (Svenska) Förlag AB and TV-Shop i Sverige AB [1997] ECR I-3843. 16 Article 2(2). 17 Article 2(3)(j), (s) and (r). 15

(C) MacMaolin Ch2

9/2/07

15:15

Page 21

2.2 Measures Equivalent to Quantative Restrictions 21 Belgian rules on the importation of whisky that was not accompanied by appropriate documentation certifying that the consignment was of Scottish origin, set out the formula by which the existence of measures equivalent to quantitative restrictions would be tested in the future.18 It was stated that ‘all trading rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are to be considered as measures having an effect equivalent to quantitative restrictions’.19 Using this formula, the Court held that an importer of Scottish whisky from Scotland to France and then into Belgium was faced with an additional burden that the importer directly from Scotland into Belgium did not face, namely that it would be more difficult for the indirect importer to obtain a certificate of authenticity. This constituted a measure equivalent to a quantitative restriction on imports. The Court had already abandoned the terms, and importance, of Directive 1970/50. There are three points to note about this decision which signal the direction that the preponderance of Article 28 EC case law has tended to follow ever since. First, it is made clear that national rules that prohibit intra-Community trade are to be treated as being either arbitrary discrimination or a disguised restriction on such trade, unless it can be demonstrated otherwise. The burden of proof on the Member State in this regard has always been very high, and in most cases almost impossible to satisfy. Second, the protection of consumers, and therefore also of scrupulous producers, was, and has remained, of little significance in Article 28 EC case law. The protection and promotion of the free movement of goods has always been of paramount importance. This has made it possible for the Community institutions generally to refrain from introducing harmonising provisions that could be used to improve consumer protection. This is because Article 28 EC, given its wide-ranging influence, can instead be used to render non-justifiable (and it must be remembered that this is a very difficult justification to make) national rules that impede free movement contrary to the terms of the Treaty. Potentially countering arguments that could be made under other areas of Treaty competence, most notably here Article 152 EC (formerly Article 129 EC) on the protection of human health and Article 153 EC (formerly Article 129a EC) on the protection of consumers, have thus remained relatively unexplored before the Court. Arguments based on Article 30 EC (formerly Article 36 EC), which provides a series of exceptions to Article 28 EC, such as public health protection, animal protection and the preservation of industrial and commercial property rights, have of course been presented on numerous occasions. However, such pleadings have had relatively little success. Third, it was demonstrated that Directive 1970/50 would not be used to provide exceptions to the promotion of free movement, the Court preferring to rely on the ambiguous terms of Article 28 EC and its own far-reaching formula on trading rules that inhibit intraCommunity trade. The directive, however, makes two points clear. Importation 18 19

Case 8/1974, Procureur du Roi v Benoît and Gustave Dassonville [1974] ECR 837. Ibid, para 5.

(C) MacMaolin Ch2

9/2/07

15:15

Page 22

22 Free Movement of Food in the EU controls inherent in the customs clearance procedure are allowable, thus including the presentation of documentary evidence supporting any claims as to origin. In particular, this is necessary for a product that has regional characteristics attached to the name under which it is marketed. It should be noted here that names relating to origin are specifically removed from possible prohibitions on Member State action set out in the directive, especially if this is a key factor in any consumer purchasing determination based on quality and/or taste and/or any other individual preference. The Court in Dassonville stated that: In the absence of a Community system guaranteeing for consumers the authenticity of a product’s designation of origin, if a Member State takes measures to prevent unfair practices in this connection, it is however subject to the condition that these measures should be reasonable and that the means of proof required should not act as a hindrance to trade between Member States.20

It is difficult to see how the national authorities could implement a system designed to prevent fraudulent practice, which is clearly allowable under the terms of the directive, where they are prevented from requiring that documentary evidence as to the origin of a product be produced. No effective Community system of guaranteeing authenticity has since been introduced to offer clarification on this matter.

2.2.2 Indistinctly Applicable Rules Whilst Dassonville signalled the intent of the Court to abandon that which had been agreed to be Community law on the free movement of goods, and develop a new jurisprudence based on the promotion of free movement, regardless of the limits placed on this by secondary legislation, this was taken a stage further by Cassis, which has proved to be the most influential single decision affecting the free movement of food.21 By holding that if a product is lawfully produced and/or marketed in one Member State it must be lawfully marketable in all Member States, the Court initiated a system of mutual recognition. Each Member State would now have to presume, unless it could prove otherwise, that the procedures in each Member State are appropriately thorough to protect consumers, either in relation to their health and general well-being, or in relation to the potential that they will be deceived into purchasing a foodstuff believing it to be one type of product when it is in fact another. The weak argument of the German authorities in Cassis, who claimed that the ban on marketing fruit liqueurs with a low alcohol content was necessary for the protection of human health and the protection of consumers from unfair commercial practices, did not help in this instance.22 It is, 20

Case 8/1974, Procureur du Roi v Benoît and Gustave Dassonville [1974] ECR 837, para 6. Case 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649. 22 See further S Weatherill, EU Consumer Law and Policy (Cheltenham, Edward Elgar, 2005), pp 57–59. 21

(C) MacMaolin Ch2

9/2/07

15:15

Page 23

2.2 Measures Equivalent to Quantative Restrictions 23 however, in relation to one of the valid claims in Cassis that the Court’s ruling has been most influential. By ruling against the national rules in this case the Court effectively created a system whereby national standards must always be reduced to the lowest level acceptable in any one of the Member States in order to comply with the interpretation of Article 28 EC. If even one Member State has no standards set in domestic law for the production and/or marketing of a particular product then no other Member State can have any such standard either. The Court responded by stating that the ‘simple matter’ of ensuring that the consumer receives appropriate information on the food label would always be sufficient to ensure their protection from unfair commercial practices.23 It did not state whether this would also be sufficient to enable consumers to protect their health.

2.2.3 Post-Cassis Free Movement of Food The Court followed up on its decision in Cassis by determining that a prohibition imposed by a Member State on the importation or marketing of apple vinegar containing acetic acid not derived from wine was contrary to Article 28 EC.24 It also added further strength to two points, which are fast becoming wellestablished facts. First, the Dassonville formula was to be consistently followed. Second, it was made explicit, even more so than in Cassis, that equal burden rules that are necessary to protect public health, ensure the fairness of commercial transactions or defend consumer interests can, where the Member State is able to satisfy the Court that their national measures are both necessary and proportionate, constitute exceptions to Article 28 EC. This renders seemingly anti-free movement national rules compliant with Community law.25 In this instance, both human health and consumer protection arguments were rejected. This was because, in the opinion of the Court, apple vinegar contains no injurious substances. The receptacles containing the vinegar were clearly labelled. Thus there was no possibility of the consumer confusing this product with wine vinegar. Cassis and Gilli and Andres make it clear that unjustifiable national compositional requirements inhibiting trade in foodstuffs contravene Community law. Later cases extend this to prohibitions based on breaches of national rules regulating the external features of food products, such as their labelling or packaging. In Fietje, for example, the Court held that a national provision prohibiting the sale of alcoholic drinks not described in a manner prescribed by domestic law, thereby making it necessary for the labels on similar products imported from other Member States to have their labels altered, is a measure equivalent to a quantitative restriction on imports, provided that the details on the original label adequately inform the consumer about the nature of the product. Again, importation 23 24 25

Cassis, note 21 above, para 13. Case 788/1979, Criminal proceedings against Gilli and Andres [1980] ECR 2071. Ibid, para 6.

(C) MacMaolin Ch2

9/2/07

15:15

Page 24

24 Free Movement of Food in the EU was not banned, but the lawful marketing of imported products was made more difficult. However, the Court also stated that national rules that prescribe the use of a description that is necessary to inform the purchaser about the nature of the product, and to enable distinctions from other products with which it might be confused to be drawn, may well be necessary in order to provide consumers with effective protection. It may even be permissible to extend such an obligation to imported products also. This is so, even where this requires the alteration of some external aspect of the product, such as the label. It was not stated as to whether this could also be extended to include internal aspects of the foodstuff setting, for example, a minimum alcohol content requirement or a stipulation that certain ingredients be used in prescribed quantities. To apply such rules to national products only would create the absurd situation whereby the domestic producer has to produce or label their product in a specific way. The importer from another Member State could either market an identical product under a different name or, worse still, market a different product under the same name. It was later established that this, combined with Dassonville, also includes any obligation that the external features of an imported foodstuff, such as labelling, be altered in any way where this cannot be similarly justified. In Fietje the Court held that the extension by a Member State of a national provision prohibiting the sale of alcoholic drinks that are not described in a manner prescribed by domestic law, thereby making it necessary for the labels on similar products imported from other Member States to have their labels altered, is a measure equivalent to a quantitative restriction on imports, provided that the details on the original label adequately inform the consumer about the nature of the product.26 Again, importation was not banned, but the lawful marketing of imported products was made more difficult. However, the Court also stated that national compositional rules for specific foodstuffs that prescribe the use of a description that is necessary to inform the purchaser about the nature of the product, and to enable distinctions from other products with which it might be confused to be drawn, may well be necessary in order to provide consumers with effective protection. It may even be permissible to extend such an obligation to imported products too. This is so even where some external aspect of the product must be altered, such as the label. It was not stated whether this could also be extended to include internal aspects of the foodstuff, for example setting a minimum alcohol content requirement or a stipulation that certain ingredients be used in prescribed quantities. To apply such rules only to national products would create an absurd situation whereby the domestic producer has to produce or label their product in a specific way. The importer from another Member State could either market an identical product under a different name or, worse still, market a different product under the same name. One problem that the early post-Cassis case law created was that Article 28 EC could only be used in situations involving some intra-Community aspect. It only 26

Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839.

(C) MacMaolin Ch2

9/2/07

15:15

Page 25

2.2 Measures Equivalent to Quantative Restrictions 25 applied where products moved from one Member State to another. This, again, could put the domestic producer at a disadvantage. Only external parties would be able to challenge national rules, no matter how much these rules might inhibit the activities of the national producer. Rules could only be challenged where a producer from another Member State, or an importer into the host State, felt that they were being prevented from operating in some way, even where all those operating in the marketplace were faced with the exact same marketing requirements. This persisted despite the fact that the producer in the Member State with the more stringent requirements would then have to compete when exporting with those who produced under more flexible rules. This would mean that, in order to be competitive, the producer in State A would have to alter its product, possibly by reducing the quality of the ingredients used, in order to level the playing field with those in State B. To some extent, this situation has improved. At least there is now recognition that a wholly domestic situation may, at some stage in the future, also include an intra-Community element if a producer from another Member State wishes to market their product in the host State whose domestic rules are under review. The Court will now examine such instances under Article 28 EC, even where there is no inter-State free movement question to be answered at the time, but only where the national rules at issue have the potential to impede market access to non-national producers in some way.27 Article 28 EC cannot be used, for example, by domestic producers against their own Member State in situations where the national rules at issue discriminate against them to the advantage of importers from other Member States.28 In Mathot, for example, criminal proceedings were brought against an operator in Belgium for marketing butter there in a package that did not bear the name and address of the processor. This contravened Belgian law.29 But there was no similar obligation placed on butter imported from other Member States—had UK or Irish butter been marketed there, the label would not have to list the producer’s name and address. It was asked whether this requirement was compatible with Article 28 EC. The Court stated that the object of this provision of the Treaty was to eliminate obstacles to the importation of goods and not to ensure that goods of national origin enjoy the same treatment as imported goods. Consequently, it was held that even where there is clear discrimination against domestically-produced goods, such a difference in treatment, given that it in no way restricts the importation, or prejudices the marketing, of imported butter, does not give rise to an infringement of Article 28 EC.

27 Joined Cases C-321/1994, C-322/1994, C-323/1994 and C-324/1994, Criminal proceedings against Pistre and others [1997] ECR I-2343, paras 44 and 45; Case C-184/1996, Commission v France (foie gras) [1998] ECR I-6197, para 17; Case C-448/1998, Criminal proceedings against Jean-Pierre Guimont [2000] ECR I-10663, para 17. 28 See, for example, Case 286/1981, Criminal proceedings against Oosthoens Uitgeversmaatschappij BV [1982] ECR 4575, para 9; Case 355/1985, Driancourt v Cognet [1986] ECR 3231, para 10. 29 Case 98/1986, Criminal proceedings against Arthur Mathot [1987] ECR 809.

(C) MacMaolin Ch2

9/2/07

15:15

Page 26

26 Free Movement of Food in the EU The free movement of vinegar was again the subject of attention in Commission v Italy.30 Here, Italy contended that vinegar should be the subject of harmonising standards before national rules prohibiting the marketing of non-wine based vinegar could be examined by the Court under Article 28 EC. This was rejected. It was stated that ensuring the free movement of goods could not be made subject to the condition that laws should first be approximated. While it was recognised that such harmonising standards could help to promote free movement of goods, this could not be considered a necessary condition for the application of such a fundamental principle of Community law.31 The fact that there are no common rules, in particular through harmonising directives, on the production and marketing of specific goods would not be sufficient to put these goods beyond the scope of the Article 28 EC prohibition. What is particularly interesting about the decision here is that the Court stated that the effects of the Italian rules prohibiting the importation of non-wine vinegar were protective in nature, even if applied to domestic and imported products alike. This was because, by closing its borders to all other types of vinegar, the Italian rules favoured a typically national product.32 The situation above has the following implication. Take a particular variety of a product. Assume that this has traditionally been favoured in a Member State, and in several, perhaps many, others. Where other varieties of the same product are produced in even a handful of other States, the importing State must not have in place any measures that prevent the marketing of that other variety in their territory, or which make such marketing any more difficult than it is for these outside producers to market their product in their own States. This adds a new dimension to the argument put forward by Germany in Cassis about the standards in all Member States having to conform with the lowest level in the Community in order to comply with Article 28 EC. Here, if all Member States bar a few (or possibly even just one) favour a particular type of product produced in a particular way, they may not, under Community law as it has developed, have in place any provisions that prevent this other variety from being marketed freely and under the same name in their territory. Just such an example was seen in relation to feta cheese, whereby the well-established method of production was left exposed to competition from a product manufactured using different ingredients and a different method of manufacture but marketed under the same sales name.33 While this may not necessarily be important in the Member State where the traditional 30

Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019. Ibid, para 17. 32 Ibid, para 20. 33 Joined Cases C-289/1996, C-293/1996 and C-299/1996, Denmark, Germany and France v Commission [1999] ECR I-1541. The decision made here has since been superseded by the introduction of Commission Regulation (EC) No 1829/2002 of 14 October 2002 amending the Annex to Regulation (EC) No 1107/1996 with regard to the name ‘feta’, [2002] OJ L 277/10, which re-registered ‘feta’ as a protected geographical food name. An application to annul this regulation under the Article 230 EC procedure was rejected by the Court in October 2005: Joined Cases C-465/2002 and C-466/2002, Germany and Denmark v Commission [2005] ECR I-9115. Discussed in more detail in Chapter 3 below. 31

(C) MacMaolin Ch2

9/2/07

15:15

Page 27

2.2 Measures Equivalent to Quantative Restrictions 27 variety originated, or for that matter in the Member States where the new variant is produced, as consumers will tend to continue to favour their own national variety, it does lead to detrimental consequences in the other Member States which do not produce feta cheese. If, for example, Denmark produces ‘feta’ using pasteurised milk from cows and a high speed filtration and production method, and it is consequently cheap to produce, but Greek producers continue to use sheep and/or goat milk and traditional slow production processes, and it is consequently more expensive to produce, it is clear who has the competitive edge in those Member States which produce neither variety. This situation becomes even more exaggerated where consumers in the importing Member State are exposed to a foodstuff for the first time and remain uneducated about the composition of the traditional variety and, in particular, the differences between the varieties of foodstuff that may all be marketed under the same name. The Court in Commission v Italy again rejected any justification based on the need to protect consumers. It found that less restrictive measures, such as clear labelling, could be used to prevent any potential confusion arising. Italy had claimed that their consumers consider all vinegar (aceto) to be wine-vinegar. Their consumers might thus be misled if other products were marketed using this name. The Court found that ‘vinegar’ was, in fact, a generic term. It would not be compatible with the objectives of the common market, and in particular the fundamental principle of the free movement of goods, if national legislation were to restrict the use of a generic term to one national variety alone to the detriment of other varieties produced in other Member States.34 It was accepted that Italian consumers might have become accustomed to the use of the term ‘aceto’ to describe wine-vinegar only. Consequently, it was accepted that the concerns of the Italian Government to protect consumers in this regard might, in fact, be justified. However, it was held that such protection could be provided by other means, such as labels describing the nature of the product sold, provided that any such requirement applied to all varieties, including wine-vinegar, to enable the consumer to make their choice in full knowledge of the facts, and guaranteeing transparency in trading by providing an indication of the raw material used to make the product.35 This is a more flexible approach than the Court was ultimately to adopt. Consider the feta situation. When Greece permitted Danish feta to be sold on their territory, but insisted that it be labelled as ‘white cheese in brine made from pasteurised cows milk in Denmark’ they were prevented from providing the consumer with just such a level of information as that advocated in Commission v Italy. Similarly, the French authorities were prevented from insisting that deep-frozen yoghurt be labelled ‘deep-frozen fermented milk’ when this too would have provided the consumer with that ‘indication of the raw material used to make the product’.36 Despite differences in production methods and/or composition, both were 34 35 36

Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019, para 26. Ibid, para 27. Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489.

(C) MacMaolin Ch2

9/2/07

15:15

Page 28

28 Free Movement of Food in the EU allowed to trade under the name of the established ‘generic’ brand from which they both differed. Other external features of foodstuffs have been tested for compatibility with Article 28 EC, including the shape of packaging in which the product is sold. It has been held, for example, that by requiring that margarine be marketed in coneshaped tubs, so that consumers could clearly distinguish it from butter, Belgium was acting contrary to Article 28 EC.37 What is particularly interesting about the reasoning in this case is that, unlike in most other Article 28 EC examinations, the Court did assess the available economic evidence supporting the assertion that the national rules at issue constituted a measure equivalent to a quantitative restriction on imports by accepting that, despite margarine prices being appreciably higher in Belgium than in other Member States, and therefore offering a more lucrative marketplace for producers from other Member States where prices were not so high, there was practically no margarine of foreign origin to be found on the Belgian market. This illustrated that, by obliging producers from other Member States to alter the shape of their packaging prior to importation into Belgium, the national rules at issue had created an obstacle to trade (although a more holistic examination may also have assessed the markets of other Member States to see whether there were large quantities of imported margarine available there). It was accepted, in principle at least, that legislation designed to prevent consumer confusion about what was butter and what was margarine was justifiable. However, by prohibiting the marketing of margarine lawfully manufactured and marketed in another Member State, the Belgian rules considerably exceeded the requirements of the objective pursued. Most importantly, consumers could be protected just as effectively in other, less trade-restrictive ways, in particular by proper labelling. In similar circumstances, in Prantl, the Court held that national rules prohibiting the use of ‘bocksbeutel’ bottles (of characteristic bulbous shape) for wines imported from Italy into Germany were contrary to Article 28 EC.38 The rules were unjustifiable on public policy and industrial and commercial property protection grounds as the bottles were lawfully used for local products in another Member State. Inconsistencies abound. An examination of the Court-developed principles on ensuring compliance with Article 28 EC at this stage identifies three key points. First, Member States may not have measures in place that force an importer to alter the name of the foodstuff on the label. Instead, measures could be introduced that force the importer to alter the description on the label.39 Second, national rules that force packaging to be altered are disproportionate to the aim pursued.40 Instead, measures should be introduced to force the importer to alter their label.41

37 38 39 40 41

Case 261/1981, Walter Rau Lebensmittelwerke v De Smedt PVBA [1982] ECR 3961. Case 16/1983, Criminal proceedings against Karl Prantl [1984] ECR 1299. Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839. Case 261/1981, Walter Rau Lebensmittelwerke v De Smedt PVBA [1982] ECR 3961. Ibid, para 17.

(C) MacMaolin Ch2

9/2/07

15:15

Page 29

2.2 Measures Equivalent to Quantative Restrictions 29 Third, where Member States have attempted to oblige importers to alter their labels they have been prevented from doing so.42

2.2.4 National Quality Requirements The preceding case law on the free movement of food seemed, temporarily at least, to be thrown into some doubt after the decision handed down in Kaas.43 At issue here were Dutch rules designed to preserve the quality of agricultural and fishery products and, more specifically, those relating to the quality of cheese. The legislation set out a list of the types of cheese that could be lawfully produced in the Netherlands. This included traditional Dutch varieties such as gouda and edam, as well as varieties traditional to other States, such as cheddar (UK) and feta (Greece). Precise production requirements were set for each variety of cheese. Products not conforming to these standards could not be lawfully produced in the Netherlands. Products from other Member States that did not meet the minimum quality standards could still be marketed in the Netherlands. It was asked whether the Netherlands was prohibited by Article 28 EC from having in place, on a unilateral basis, rules concerning the quality of cheese, such as those at issue. The case centred around the question of whether these rules, given that they were designed to improve the quality of domestic production and thereby increase the sale of such products, were capable of placing imports at a disadvantage and therefore constituted a measure having an effect equivalent to a quantitative restriction. It was held that Article 28 EC does not prevent a Member State from adopting domestic rules which do not set standards for imported products but have as their purpose the improvement of the quality of domestic production so as to make it more attractive to consumers. The rules at issue here were distinguished from other, similar domestic measures which may be contrary to Article 28 EC, such as publicity campaigns designed to promote domestic products,44 or those which advise consumers to purchase domestic products solely by reason of their national origin.45 It is here contended that this distinction is not so clear-cut. The decision in Kaas differs from the generally accepted reasoning of the Court on Article 28 EC matters. Domestically produced cheese that carries a quality certification stamp has a clear marketing advantage over an imported cheese that does not carry this mark. There are two reasons for this. First, the consumer is informed that the cheese has met minimum quality guarantees. Second, the consumer is informed that the cheese has been produced within the Member State. Consumers tend to favour domestically produced goods over imported ones—for a variety of 42 See, for example, Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489; Joined Cases C-289/1996, C-293/1996 and C-299/1996, Denmark, Germany and France v Commission [1999] ECR I-1541. 43 Case 237/1982, Jongeneel Kaas BV and others v Netherlands and other [1984] ECR 483. 44 Case 249/1981, Commission v Ireland (Buy Irish campaign) [1982] ECR 4005. 45 Case 222/1982, Apple and Pear Development Council v KJ Lewis Ltd and others [1983] ECR 4083.

(C) MacMaolin Ch2

9/2/07

15:15

Page 30

30 Free Movement of Food in the EU reasons.46 A scheme such as that at issue here may thus have a far more restrictive effect on intra-Community trade than may, for example, a national rule obliging a producer to market margarine in cone-shaped tubs. By placing such an obligation on imported margarine the Member State makes the product look similar to the domestically produced variety. Were importers to continue to market their margarine in differently shaped tubs it would immediately draw the consumer’s attention to the fact that the good in question is imported. Similarly, here the consumer is automatically informed that cheese has not been produced in accordance with national minimum quality requirements and that it is foreign, thereby reducing the possibility of the average consumer purchasing it. Despite the decision in Kaas, national rules that seek to preserve the quality of products tend to be deemed contrary to Article 28 EC obligations in practically all circumstances, even where the sale of imported goods that meet these standards remains uninhibited by the Member States. In Miro, for example, Dutch rules restricting the use of the sales name ‘jenever’ to a type of drink meeting domestic national requirements including, in particular, the requirement that it have an alcohol content of at least 35 per cent, came under the scrutiny of the Court.47 A retailer was prosecuted for selling imported Belgian ‘jenever’ with an alcohol content of only 30 per cent. At the time, the Commission had proposed a regulation laying down general rules on the definition, description and presentation of alcoholic spirits, including jenever, for which it had set a minimum alcohol content of 30 per cent.48 The Council had not yet taken any decision on this proposal, however. The national court had found that, given the decision in Cassis, coupled with the fact that the label made it clear that the product was in fact Belgian jenever, there was no mandatory requirement of consumer protection that would justify banning the sale of the imported product in the Netherlands. However, it was noted that this would then place the Dutch jenever producer at a disadvantage. They would remain subject to additional excise duty and value added tax given that their variant of the product would have to contain at least five per cent more alcohol than the imported variety. The Dutch and German governments claimed that the national rules were justified by mandatory requirements for con46 For further discussion see K Philp and L Brown, ‘Does Consumer Ethnocentrism Impact on Australian Food Buying Behaviour?’ (2003) Journal of New Business Ideas and Trends 21, where it is accepted that as globalisation intensifies, consumers’ perceptions of foreign products, and hence the country of origin effect also intensifies. See also SM Peris, K Newman, E Bigne and B Chansarkar, ‘Aspects of Anglo-Spanish Perceptions and Product Preferences Arising from “Country-of-Origin” image’ (1993) 12 International Journal of Advertising 131; S-T Hong and RS Wyer, ‘Effects of Countryof-Origin and Product-Attribute Information on Product Evaluation: An Information Processing Perspective’ 16 (1989) Journal of Consumer Research 175. 47 Case 182/1984, Criminal proceedings against Miro BV [1985] ECR 3731. 48 Proposal for a Council regulation (EEC) laying down general rules on the definition, description and presentation of spirituous beverages and of vermouths and other wines of fresh grapes flavoured with plants or other aromatic substances. COM (1982) 328. [1982] OJ C 189/7. This proposal became Council Regulation (EEC) No 1576/1989 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks. [1989] OJ L 160/1. Jenever was later specifically removed from the scope of Article 3 of the Regulation, which set minimum alcohol contents for other classifications of spirituous beverages, such as whiskey (40%), rum (37.5%) and gin (also 37.5%).

(C) MacMaolin Ch2

9/2/07

15:15

Page 31

2.2 Measures Equivalent to Quantative Restrictions 31 sumer protection as labelling measures are insufficient to eliminate the risk that the consumer may confuse the traditional beverage with another product having a lower alcohol content. This would be particularly so where they are unaware that the traditional variety should contain 35 per cent alcohol. Such measures, it was contended, are completely ineffective where the beverage is sold in hotels and restaurants. Germany also suggested that the question of the validity of the Dutch restriction on the use of the name ‘jenever’ should be determined by reference to the commercial view prevailing in the country concerned and, given that the national authorities are in the best position to judge on this matter, it should be for those authorities, and not the Court of Justice, to reach any decision in this regard. This argument was rejected. The Court found that the national court had itself accepted that the labelling disclosures on the product were sufficient to inform the consumer about the nature of the difference between the two varieties of jenever. As a consequence, it was only deemed necessary to ascertain whether the need to ensure fair trading could be used to justify the Dutch rules. The Netherlands put forward the argument, and they were supported by Italy in this regard, that an alcohol content of 35 per cent is one of the inherent characteristics of this traditional national product. Without a ban on using the traditional name for a product not having the traditional qualities, it would be impossible to maintain its quality. A situation would be created whereby even beverages with an alcohol content as low as 15 per cent would have to be accepted as ‘jenever’. Producers should therefore, it was claimed, be prevented from using the good reputation of a world-famous product to the advantage of the different and cheaper product. The Court, however, referring to Commission v Germany 49 and Commission v Italy,50 stated that it was not compatible with Article 28 EC for national legislation to be allowed to restrict the use of a generic term to one national variety alone to the detriment of other varieties by compelling producers of other varieties in other Member States to use sales names which are either unfamiliar or less esteemed by the consumer. It was recognised that setting compositional requirements could, of course, lead to standardisation and, consequently, provide more transparency in trading. However, following its earlier determinations on the matter, the Court found that in a common market, fair trading interests are to be examined in the context of the fair and traditional practices of all Member States.51 It could not therefore be regarded as an essential requirement of fair trading that national rules fixing minimum alcohol content be complied with by products of the same kind imported from another Member State if they are lawfully and traditionally manufactured and marketed under the same name in the Member State of origin and the purchaser is provided with the proper information.

49 50 51

Case 12/1974, Commission v Germany (sekt) [1975] ECR 181. Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019. Case 16/1983, Criminal proceedings against Karl Prantl [1984] ECR 1299.

(C) MacMaolin Ch2

9/2/07

15:15

Page 32

32 Free Movement of Food in the EU The Court summarised its position by stating: If in such circumstances the free movement of imported goods were to be subject to the condition that there should first exist Community rules, the fundamental principle of a unified market and its corollary, the free movement of goods would be rendered meaningless.52

The fact that the imported product may have a price advantage as a result of the application of national taxes and duties proportional to the alcohol content was deemed irrelevant here.53 The Court stated that these are part of the objective conditions of competition. Every trader may freely take advantage of these, provided that purchasers are given information so that they are free to make their choice on the basis of the quality and price of the products.54 The Court essentially states in Miro that the mutual recognition principle developed in Cassis is not only here to stay but it leaves producers with the following choice. Maintain quality standards and compete with lower priced competitors who are selling lower quality products, or reduce the quality of your own products to meet this new element of competition accordingly. There is also recognition by the Court here that harmonisation of Member States’ rules on compositional requirements is no longer necessary given the efficacy of Article 28 EC and related case law in ensuring the free movement of foodstuffs.55 This reasoning persists despite the Court’s own recognition in Miro that setting standardised compositional requirements could provide more transparency in trading, leading to fairer trading amongst producers, whilst clearing up any confusion that could be created amongst consumers. The Court will also refuse to accept the necessity of national rules designed to maintain the quality of food where the Member State imposing them fails to provide that these standards are being properly upheld. In Commission v Italy, for example, it was asked whether certain national rules contravened Article 28 EC.56 These rules required that edible vegetable oils imported from other Member States, other than olive oil, should not be marketed unless colour-reactive sesame oil was added. Italy claimed that this obligation was necessary to prevent fraudulent practices intended to deceive consumers, in particular in the olive oil sector. A lack of effective controls on either domestic production or imports to check that sesame oil had been added, and the fact that the national measures were unlikely to achieve the aim pursued effectively, led the Court to declare this provision contrary to Article 28 EC. What is also clear from the Court’s Article 28 EC jurisprudence on the legality of national quality standards is that it is irrelevant whether or not the Member State actually prohibits the sale of a food lawfully marketed elsewhere in the 52 53 54 55 56

Case 182/1984, Criminal proceedings against Miro BV [1985] ECR 3731, para 25. Ibid, para 26. Ibid. Discussed further in Chapter 3 below. Case C-67/1988, Commission v Italy (sesame oil) [1990] ECR I-4285.

(C) MacMaolin Ch2

9/2/07

15:15

Page 33

2.2 Measures Equivalent to Quantative Restrictions 33 Community. All that is required to make the rule examinable for compatibility with the Treaty is that it obliges the importer who does not meet the national standards to market their product using a different name. This has already been demonstrated in Miro. In Commission v Germany, the Court made it clear that its intention was to ensure, as far as possible, that no domestic rules inhibiting the lawful marketing of products from other Member States would be safe from its now sprawling Article 28 EC jurisprudence.57 Here, the national rules at issue were the sacrosanct German beer purity laws (Biersteuergesetz). These rules set method of manufacture and compositional requirements that had to be adhered to by both domestic producers and those from other Member States in order for them to lawfully market their products as ‘bier’ in Germany. ‘Bier’ could only contain malted barley and some other malts (artificially germinated cereals other than, amongst others, rice and maize), hops, yeast and water. Beverages not meeting these requirements could still be marketed, but only under a different name. German law also prohibited the marketing of ‘bier’ containing unauthorised additives, for health protection reasons. This latter aspect of the judgment will be dealt with later in this chapter. The Commission objected to the German rules. It was claimed that they precluded the importation into Germany of many beers that were lawfully manufactured in other Member States. The Commission did not believe that such a prohibition could be justified on grounds of either consumer protection or safeguarding public health. Germany disagreed. It claimed that if only those ingredients that were listed in its domestic rules were used in manufacturing beer, there would be no need to use additives. The Commission accepted that in the absence of Community harmonisation, Member States could lay down rules such as those at issue. Its primary complaint was, however, that these rules could not be used to limit the use of a generic name to those products that conformed to these standards, such rules going beyond that which was necessary to protect the German consumer who could be informed about any differences between products marketed under the same name on the labelling. Citing Cassis58 and Rau,59 the Court noted that such rules may be necessary to protect consumers or human health, but, most importantly, that any such rules must be proportionate and that where a Member State can choose between various measures to attain the same objective, it should choose the means that is least restrictive on the free movement of goods. There was clearly an obstacle to trade. It just had to be ascertained whether this could be justified. The argument that the German rules were necessary to protect consumers who associated the designation ‘bier’ only with the beverage manufactured solely from the ingredients specified was rejected. It was held that consumer conceptions are likely to evolve over the course of time within a Member State. The common market, it was stated, would play a major contributory role in that development. 57 58 59

Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. Case 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649. Case 261/1981, Walter Rau Lebensmittelwerke v De Smedt PVBA [1982] ECR 3961.

(C) MacMaolin Ch2

9/2/07

15:15

Page 34

34 Free Movement of Food in the EU The German rules, it was claimed, were thus preventing this evolutionary process from taking place. In support of this, Commission v UK was cited.60 There it was stated that the legislation of a Member State must not ‘crystallise given consumer habits so as to consolidate an advantage acquired by national industries concerned to comply with them’. Secondly, the designation ‘bier’ was used generically in other Member States where rice or maize was permitted to be added to the beverage, and it was this definition that was used in the common customs tariff (heading no 22.03).61 Providing consumers with information about the ingredients used and method of manufacture employed, as the German bier designation did, was seen to be a legitimate labelling function. However, the Court determined that this goal could be better satisfied by measures that were less restrictive on free movement. In particular, this could be achieved by the compulsory affixing of suitable labels identifying the nature of the product sold.62 The Court stated that where there are clear indications of the raw materials used, the consumer can make his or her choice in full knowledge of the facts. This will guarantee transparency in trading. Such a system of mandatory consumer information could not entail negative assessments for beers not complying with the German rules. In saying so, this was perhaps to admit that the German rules led to the production of a superior product and certainly a product which German consumers found more desirable. The problem that this information might be more difficult to transmit to those purchasing draft beers was seen to be surmountable. Information could be placed on either the casks or the beer taps. However, such a presumption by the Court is clearly questionable. Generally consumers of beer do not inspect the casks to read the labels before consuming the drink. As the case law of the Court of Justice on Article 28 EC has developed, it has become clear that where a Member State attempts to apply national legislation that prohibits two different products being marketed under the same sales name, it will generally be prevented from doing so.

2.2.5 Different Products, Same Name In similar circumstances to those that led to the nullification of the German beer purity laws,63 Italian requirements that pasta be made using only durum wheat 60

Case 170/1978, Commission v UK (wine and beer tax) [1980] ECR 417. Council Regulation (EEC) No 2658/1987 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff. [1987] OJ L 256/1. Combined nomenclature definitions were also scrutinised in Joined Cases C-465/2002 and C-466/2002, Germany and Denmark v Commission [2005] ECR I-9115, where it was argued that CN Code 0406 9031 clearly classified ‘feta’ cheese as a generic food product. However, it was stated that this system of classification applied to customs matters only and was not relevant to any assessment of industrial property rights and could not therefore be used in any examination of how the product should be defined for protected designation of origin purposes under the terms of Regulation 2081/1992 (since replaced by Regulation 510/2006). Discussed in more detail in Chapter 3 below. 62 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227, para 35. 63 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. 61

(C) MacMaolin Ch2

9/2/07

15:15

Page 35

2.2 Measures Equivalent to Quantative Restrictions 35 were challenged in Zoni.64 Here, an Italian wholesaler imported pasta from Germany. The pasta in question was made from a combination of common wheat and durum wheat. Domestic law in Italy prohibited the sale of both domesticallyproduced and imported dry pasta made using such a mixture. The use of common wheat was permitted for the small-scale manufacture of fresh pasta, either for immediate consumption or exclusively for export. Italy contended that the domestic rules were designed to guarantee the quality of pasta and to promote the growing of durum wheat. Producers of this crop have scarce alternative markets for their product in the Community other than the pasta market. They have no real possibility of changing over to other crops in the Mezzogiorno regions in which they are established. The Dassonville formula was readily satisfied: this was clearly a measure equivalent to a quantitative restriction. The decision in Cassis, however, created the possibility of justification based upon one of the mandatory requirement exceptions. The consumer protection argument was dismissed, in particular on the basis of the findings in Commission v Germany.65 The Court found that labelling would offer a more proportionate solution to the aim pursued. The framework food labelling directive made it possible for Italy to reserve the description ‘pasta made from durum wheatmeal’ for products made exclusively from this ingredient.66 The possibility of confusion or deception where pasta is served in restaurants could, it was claimed, be avoided by establishing a system of informing the consumer about the nature of the pasta being offered. Italy offered counter-arguments that were rejected. Italian consumers associate the sales name ‘pasta’ with products made exclusively from durum wheat, hence the requirement to maintain domestic rules. The name ‘pasta’ is a generic one. Italian legislation allowed, in some circumstances, products not made from a combination of wheat types to be called pasta, for example, pasta for export. The fair trading argument was rejected on the basis that, although pasta made exclusively from durum wheat was more expensive to produce than that containing common 64 Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285. See also Case 407/1985, Glocken GmbH and Kritzinger v USL Centro-Sud and Provincia autonoma di Bolzano [1988] ECR 4233. 65 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. Also cited here, Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019. 66 Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285, para 17. While no specific reference is made here by the Court to a particular provision of Directive 1979/112, presumably it is referring to Article 5(1) thereof which provided: ‘The name under which a foodstuff is sold shall be the name laid down by whatever laws, regulations or administrative provisions apply to the foodstuff in question or, in the absence of any such name, the name customary in the Member State where the product is sold to the ultimate consumer, or a description of the foodstuff and, if necessary, of its use, that is sufficiently precise to inform the purchaser of its true nature and to enable it to be distinguished from products with which it could be confused.’ However, the new framework food labelling directive, Directive 2000/13, adds a new Article 5(1)(b) which provides that: ‘The use in the Member State of marketing of the sales name under which the product is legally manufactured and marketed in the Member State of production shall also be allowed.’ Therefore, it is debatable as to whether the assertion made here by the Court about Italy being permitted to prescribe the use of a specific sales name for pasta where it is lawfully marketed using that name elsewhere in the Community is now in doubt. Considering Cassis, and related case law discussed previously in this chapter, it is highly probable that this would never actually have been allowed in the first instance given the apparent absence of any ‘substantial difference’ between the products concerned.

(C) MacMaolin Ch2

9/2/07

15:15

Page 36

36 Free Movement of Food in the EU wheat, Italy could, as stated previously, reserve the use of the sales description ‘pasta made from durum wheatmeal’ to products made exclusively from this ingredient, enabling Italian consumers to express their preference for the product to which they had become accustomed and guaranteeing that the difference in price would be justified by an appreciable difference in quality. This would now oblige the national producer to alter their label, while the importer could continue to market their product using the original sales name. Finally, the producer protection argument, which Italy claimed could lead to grave social and environmental consequences, was dismissed on the basis that Italian producers could still be required to adhere to the domestic requirements and that export markets largely favour durum wheat pasta, even where also exposed to competition from the less expensive mixed wheat variety. The Italian rules were held to be contrary to Article 28 EC, not being justifiable under any of the Court-developed mandatory requirement provisions. The compatibility of national rules prohibiting the marketing of milk substitutes with the terms of Article 28 EC was first examined in Commission v France.67 Here, the respondent Member State argued that the measures were necessary for both consumer protection and health preservation reasons. Applying its previous case law on the matter, the Court reiterated that Member States may not invoke public interest or mandatory requirement grounds to justify a measure restricting imports unless the same objective could not be achieved by another measure that was less restrictive on the free movement of goods. France put forward three consumer protection arguments: (i) the difficulties in informing consumers that what they were purchasing was in fact a substitute product; (ii) consumers may be confused as to the characteristics of the product; and (iii) cheaper substitutes will gradually supplant the original variety, ultimately limiting consumer choice. Once again, the Court answered the first argument with the labelling information panacea, in this case where it listed details of the nature, the ingredients and the characteristics of the product on offer. This information could also, it was claimed, be provided, in principle at least, in catering establishments. While it was accepted that there may be some difficulties in providing consumers with full and detailed information where milk substitutes are used in catering, it was also noted that this level of information is not given about the other ingredients used in foodstuffs and meals provided by catering establishments. There was no reason to have more strict requirements in place for milk substitutes than for other foods.68 The Court accepted that some national measures designed to ensure clear labelling may be adopted without infringing free movement rules.69 The stated position, therefore, was that Community law does not preclude a national measure that seeks to secure accurate consumer information and thereby assists in 67

Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. Ibid, para 10. 69 See also, in particular, Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839. 68

(C) MacMaolin Ch2

9/2/07

15:15

Page 37

2.2 Measures Equivalent to Quantative Restrictions 37 avoiding any confusion about the nature of a product. However, the measures adopted in this case were seen to go beyond this, given that they put a prohibition in place. They were not proportionate to the stated aim pursued. As to the risk of milk products becoming supplanted by lower priced substitutes, the Court stated that a Member State may not plead a mandatory requirement, such as consumer protection, in order to shield a product from the effects of price competition, on the pretext of economic difficulties brought about by the elimination of barriers to intra-Community trade.70 Choice, it was stated, would not become restricted. Instead, it was only through the marketing of products like substitute milk that consumers would be presented with a genuine choice between whiteners and real milk products. The prohibition was thus found to be unnecessary for consumer protection purposes. Whether this really presents a proper choice for the consumer is questionable. Where catering or processed foodstuff production establishments are concerned, the consumer does not actually have a choice. The alternative version has already been used in production and is then contained in the finished product. It is also highly unlikely that consumers in catering establishments will ever be informed of this substitution. Perhaps most controversially, however, the French argument that Regulation 1898/1987 could be used to support the legitimacy of their domestic measures was also not accepted because that legislation provides that only those national regulations that comply with the general provisions of the EC Treaty could be maintained.71 These national regulations did not, given that which had been stated previously by the Court, satisfy this requirement as they were contrary to Article 28 EC. Article 5 of the regulation actually states that: Member States may, until the end of the fifth period of application of Article 5c of Regulation (EEC) No 804/68 and in compliance with the general provisions of the Treaty, maintain their national regulations which restrict the manufacture and marketing in their territory of products not fulfilling the conditions referred to in Article 2 of this Regulation.

It does not state, nor is it stated anywhere else in the regulation, that this is confined to national measures that comply with all aspects, or even the general provisions, of the Treaty. The regulation was actually designed to promote milk consumption; to protect milk and milk products in the interests of Community producers and consumers; to ensure appropriate labelling to prevent the consumer from being misled; to define milk and milk products; to avoid any confusion on the part of the consumer between milk products and other food products, including those consisting partly of milk components; to establish conditions of competition between milk products and competing products in the field of product designation, labelling and advertising which avoid any distortion, and to protect the consumer in this regard; given that milk products have a higher 70

Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793, para 12. Article 5 of Council Regulation (EEC) No 1898/1987 of 2 July 1987 on the protection of designations used in marketing of milk and milk products. [1987] OJ L 182/36. 71

(C) MacMaolin Ch2

9/2/07

15:15

Page 38

38 Free Movement of Food in the EU production cost than substitutes, to safeguard agricultural producer incomes; and to enable Member States having already taken national measures to curb the manufacture and marketing of these substitute products on their territory to maintain their regulations, in compliance with the general rules of the Treaty.72 The preamble to the regulation does specify the need for compliance of existing national rules, such as those at issue here, with the Treaty. However, if this aspect of the preamble could be used by the Court to declare the French rules incompatible with the Treaty, then it needed also to be ascertained whether the other declarations made in this part of the regulation could have been used to support the French ban. Were such an assessment to have been made, then it could clearly have been identified that the French rules were in compliance with Community law and policy, even if contrary to Article 28 EC. Certainly, it would have made justification of the national rules under Article 30 EC more readily acceptable. To adopt any other approach would render Regulation 1898/1987 virtually meaningless. The Court was faced with an examination based on a similar set of circumstances in Commission v Germany.73 Again German law prohibited the marketing of milk substitutes. Germany suggested that this prohibition was confined to imitations of milk, which could be confused with real milk, and not milk substitutes as such. The mandatory requirement justification put forward, that this was necessary to protect consumers, was also rejected here. One additional defence put forward by Germany was that the nature of the rules at issue, which only sought to prohibit the marketing of those products that could reasonably be confused with real milk, clearly identified that their aim was to protect consumers from being misled. The prohibition could not thus be said to have a trade restricting intention. It was also claimed that the rules at issue were proportionate as no other measure would be sufficient to protect consumers in this way. This was not accepted. Adequate labelling would suffice. The Court also noted that even where these drinks were sold in vending machines or catering establishments, consumers could also be provided with full and detailed information on the nature of the products. This is, however, unlikely to happen. While it was noted that some difficulties may arise here, this was a problem that applied to all foodstuffs provided in such a way and that there was no particular reason why a higher level of information should be required to be supplied to consumers where milk substitutes were involved. Again, such reasoning is questionable. It is perfectly reasonable that extra information should be provided to consumers when purchasing products that are different from that which they would normally expect. This is especially so where the products involved are different but are marketed using the same name and where there is a clear possibility of confusion or deception in some circumstances, such as where the products are sold in catering establishments or by vending machine. The Court’s own case law makes provision for this. Its entire 72 Preamble to Council Regulation (EEC) No 1898/1987. For discussion of the role of agriculture in the EC Treaty more generally see JA McMahon, Law of the Common Agricultural Policy (Harlow, Longman, 2000). 73 Case 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021.

(C) MacMaolin Ch2

9/2/07

15:15

Page 39

2.2 Measures Equivalent to Quantative Restrictions 39 free movement of food jurisprudence is based on the presumption that providing additional labelling information to consumers should counter almost all Member State contentions that their national rules that inhibit free movement in some way are justifiable. It was accepted, following Fietje,74 that reasonable national measures that are necessary in order to ensure that products are accurately described do not themselves infringe Article 28 EC. However, the measures at issue here were found to go beyond this, again failing the test of proportionality to the aim pursued. As in Commission v France, the Regulation 1898/1987 argument was also here rejected.75 It was stated that the national measures, although appearing to satisfy Article 5 in conjunction with Article 2 thereof, could not be maintained as they were contrary to Article 28 EC, and thereby did not satisfy the terms of the regulation. In the milk substitute cases, the Member States sought to justify national rules that prohibited the sale of foodstuffs using the generic name of a product from which the foodstuff in question differed significantly. These cases can be distinguished from those where the national rules under examination prohibit the use of a generic name, even where the two ‘different’ foods concerned are almost identical. In Nespoli and Crippa,76 for example, it was questioned whether Italian national rules specifying the minimum fat content of cheese were compatible with Article 28 EC. The minimum fat content for the type of cheese in question was set by the national rules at 45 per cent. The two defendants in the domestic legal action were charged with the importation and marketing for sale respectively of a French cheese containing only 30 per cent fat. It was sold in its original French wrapping, being labelled as ‘fromage demi-gras’ (semi-fat cheese). A label had also been attached bearing the Italian words ‘prodotto caseario’ (cheese product). The effect of the domestic law was to prevent cheese lawfully produced and marketed in one Member State from being lawfully marketed in another under the same generic name: ‘cheese’. Italy contended that the rules were designed to protect consumers as their legitimate expectations would not be satisfied if they were offered as cheeses products which, in view of the differences between the national rules, exhibited very different characteristics and were thus different products. This was rejected. The use of adequate labelling would suffice in order to provide proper information on the actual fat content to enable consumers to make their choice with full knowledge of the facts. Similarly, in van der Laan it was held that national rules that prohibited the marketing as ‘meat product’ a foodstuff that contained only 70 per cent meat was contrary to Article 28 EC.77 The Member State had contested that given the low level of meat actually contained in the product, it was so markedly different from other cured meat with a 100 per cent actual meat content that labelling disclosures 74

Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839, para 11. Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 76 Case C-196/1989, Criminal proceedings against Enzo Nespoli and Giuseppe Crippa [1990] ECR I-3647. 77 Case C-383/1997, Criminal proceedings against Arnoldus van der Laan [1999] ECR I-731. 75

(C) MacMaolin Ch2

9/2/07

15:15

Page 40

40 Free Movement of Food in the EU would not suffice to indicate the real level of difference between the product types. This argument was rejected, the Court finding that consumer protection grounds could not be successfully invoked here to justify this restriction on the free movement of food. Consumers would, it was claimed, be sufficiently protected by descriptive labelling and the information available in the list of ingredients. A comparison of the decisions in the milk substitutes cases to that in Nespoli and Crippa on the fat content of cheese highlights a problem with the prevailing remedy that the Court offers to deal with the fact that Member States have different compositional requirements for the same food products. In the milk substitutes cases, a significant difference existed between the prohibited product and foodstuffs normally marketed using that name. The Italian rules on the fat content of cheese prohibited the marketing of products not meeting the required standard even as ‘cheese substitutes’, despite the fact that both products contained a significant fat content, and both could be considered as being cheese, one full-fat, the other reduced-fat. This would be similar to the milk substitutes cases examining, not whether a substitute product should be allowed to use the universally recognised generic name, but instead testing national rules that prohibited the sale of semi-skimmed or low-fat milk as such. In other words, preventing such products from using the word ‘milk’ in their sales name. The Court, however, directed in both situations that the national rules were contrary to Community law. Labelling disclosures of difference between products would be the more proportionate response. This is disputed here. Two levels of difference between products are examined. One level of difference, that in the milk substitutes cases, is substantial. The other level of difference, that between full-fat and reduced-fat cheese, is relatively inconsequential. Levels of difference require different treatment by the Court. The two sets of rules under examination impact differently on consumer protection. The French and German rules on milk substitutes prevent consumers from being deceived into purchasing a product that is quite unlike real milk. The Italian rules on fat content levels in cheese prohibited low-fat cheese from being called cheese, even though it is admittedly a kind of cheese. It could be noted here that the circumstances under examination in Nespoli and Crippa are not that dissimilar to those in Cassis. There is, however, one key difference. The cheese was labelled as ‘semi-fat cheese’ or ‘cheese product’. In Cassis, the liqueur bore no such description. It was not labelled as ‘low alcohol liqueur’. If it were, it could be argued that this instantly brings this ‘inconsequential difference’ to the consumer’s attention. For such inconsequential differences, Member States should, of course, be allowed to allow the product to be marketed on their territory using the more descriptive form of labelling, such as that which the Court appears to be advocating in Zoni. For any ‘substantial difference’ further investigation into the degree of difference between products is required in order to ascertain whether a Member State prohibiting the use of the name of the food normally known by that name should be permissible. An outright prohibition on the sale of the foodstuff, unless justifiable under Article 30 EC, should never be allowed. A realigned interpretation of

(C) MacMaolin Ch2

9/2/07

15:15

Page 41

2.2 Measures Equivalent to Quantative Restrictions 41 Community law would, however, permit Member States to prescribe the use of an alternative name in such circumstances. There is one further difference to note between the national rules prohibiting the sale of milk substitutes and those stipulating the minimum fat content for cheese. For virtually everybody low-fat cheese is a better dietetic choice than fullfat cheese. But milk substitutes could be considered nutritionally or dietetically superior to milk itself for very few people. The latter has the potential to impact positively on human health; the former negatively. It has become clear since the decision of the Court in Cassis that once a product is lawfully marketable in one Member State, it must be lawfully marketable in all— this is the principle of mutual recognition. Essentially, this principle obliges all Member States to concede that the standards set for the production and marketing of foodstuffs in all other Member States, for all food products lawfully marketable there, are of an acceptable level. This is clearly not the case. As a consequence, Member States become obliged to allow the lawful marketing of a variety of foodstuffs, perhaps composed of entirely different ingredients leading to the creation of an entirely different product, using the same food name. This is even the case for the Member State where a foodstuff has been produced by a traditional method and using traditional ingredients for generations, such as pasta or ‘bier’. Such food names are deemed to be generic. Given the manner in which the case law of the Court of Justice has developed on this matter, all such food names may be used by any producer in any Member State producing something that resembles the original variety. Fat content may be reduced below minimum standards, ingredients may be altered, traditionally alcoholic drinks need not contain alcohol and powdered substitute varieties can be marketed in a manner that conceals this from the consumer, who is likely to believe that they are purchasing something else altogether. The Court has made one concession here. It will, albeit in very limited and illdefined circumstances, allow Member States to introduce measures to prevent the marketing of ‘substantially different’ products using the same food name, generic or otherwise. Just how limited and ill-defined this level of difference has come to be is examined in more detail below.

2.2.6 Substantial Difference between Food Products Two of the most important Court determinations on the circumstances in which a mandatory requirement exception to the free movement of food may be successfully invoked were those delivered in Smanor78 and Deserbais.79 In Smanor, French rules prohibited the deep-freezing of yoghurt, prescribing that after coagulation, the only processes or treatment to which the product could be subjected 78 79

Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489. Case 286/1986, Ministère public v Gérard Deserbais [1988] ECR 4907.

(C) MacMaolin Ch2

9/2/07

15:15

Page 42

42 Free Movement of Food in the EU were refrigeration and stirring. Minimum quantities of live bacteria were also set (100 million per gram). Smanor, a French company, had been marketing deep-frozen yoghurt in France. The national authorities wished to prohibit the marketing of their products unless sold as ‘deep-frozen fermented milk’. The validity of the French rules was tested under both Article 28 EC and the framework food labelling legislation.80 The French authorities contended that Article 28 EC did not apply to the facts of the case: this was a French company operating in France contesting French rules, and there was therefore no intraCommunity trade element. This was rejected. The Court, for the first time where the free movement of food was concerned, found that while this was the case, it could not be ruled out that products such as those at issue may, at some stage in the future, be imported into France and thus be subject to the French legislation.81 Article 28 EC thus applied to a wholly internal situation.82 The contested rules were caught within the definition of a measure equivalent to a quantitative restriction as set by the Court in Dassonville, and presented a similar form of trade impediment to those that were reviewed by the Court in Fietje.83 The Court accepted that the sales name ‘deep-frozen fermented milk’ was less familiar to consumers than ‘deep-frozen yoghurt’. The rules at issue were examined to see whether they could be justified on consumer protection grounds. It is of course legitimate for a Member State to ensure that consumers are properly informed about the products that are offered to them, enabling them to choose on the basis of that information.84 Consumers could, however, make such a choice where the goods are labelled adequately, with the compulsory inclusion of the description ‘deep-frozen’ to show the treatment that the product has undergone.85 This position would only alter if, having undergone the deep-freezing treatment, the yoghurt no longer had the characteristics which the consumer expects when buying this product. Using Codex Alimentarius standards,86 and an assessment of several Member States’ regulations, the Court identified that the characteristic feature of yoghurt is the presence of abundant quantities of live bacteria. As a consequence, the Court found that the national rules appeared disproportionate in relation to the objective of consumer protection when the characteristics of the deep-frozen variety were not ‘substantially different’ to fresh yoghurts, particularly as regards the quantity of bacteria. When appropriate labelling was attached 80 Then Council Directive 1979/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer. [1979] OJ L 33/1. Discussed in more detail in Chapter 3 below. 81 Case 298/1987, Smanor, note 79 above, para 8. 82 It has also been argued that national rules cannot be examined under Article 28 EC where very little of the foodstuff type that is subject to these rules is produced in other Member States. This has, of course, been firmly rejected by the Court. See Case C-184/1996, Commission v France (foie gras) [1998] ECR I-6197, paras 14–17. 83 Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839. 84 Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 85 Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489, para 19. 86 Now Codex Standard for Fermented Milks, Codex Standard 243/2003.

(C) MacMaolin Ch2

9/2/07

15:15

Page 43

2.2 Measures Equivalent to Quantative Restrictions 43 to the product, consumers would be properly informed. It would, however, be for the national court to determine, in the light of the information available to it, whether the difference between deep-frozen yoghurt and the product meeting the national rules relating to fresh yoghurt was sufficient to require a different sales name.87 The Court thus opened up the possibility that Member State rules restricting the free movement of food may actually be compatible with Article 28 EC where there is a ‘substantial difference’ between the imported product (or domestically produced as in Smanor) and the variety generally known by that sales name, which is subject to national compositional rules. Two months later, in Deserbais, the Court made a similar assessment on whether French rules were compatible with Article 28 EC.88 These rules prohibited the marketing of German edam cheese with a fat content that fell below the level required by domestic law. The French rules were adopted on the basis of the standard for edam set down in the Stresa Convention, which stipulated that it must have a minimum fat content of 40 per cent. The German edam at issue had a 34.3 per cent fat content. Although finding that the French rules were incompatible with Article 28 EC, the Court did again here find that, in some circumstances, where there is a substantial difference in composition or production method from products generally known by that name in the Community, such that they could not be regarded as being the same product, then an exception to Article 28 EC may exist. Peculiarly, the Court in Nespoli and Crippa never referred to Deserbais, decided over two years earlier, in its judgment. This despite the two cases being bases upon largely similar facts. The Court also found that the standards set by the Stresa Convention and the Codex Alimentarius, both of which laid down a minimum of 40 per cent fat content for edam cheese, could not be relied upon to prove that the difference between the products at issue here was substantial. It was stated that these standards are in fact only designed to provide guidance, not to enable Member States to introduce prohibitions where these are not met.89 In a 1991 communication the Commission examined the Smanor and Deserbais judgments and proposed criteria for identifying the characteristics of a product that may make it unsuitable for selling under a generic name in the State of destination.90 Any test must be carried out on the subjective basis of consumer expectations and the objective bases of Codex Alimentarius definitions, the rules and regulations of the Member States and the composition or method of manufacture of the products. In the Commission’s opinion, only a substantial difference in one of those respects from national products would permit the importing State to prevent the imported product being marketed under the generic name. However, the Commission failed to lay down the degree of difference required to render this substantial, nor did it state any order of priority for consideration of the criteria. 87

Case 298/1987, Smanor, note 86 above, para 24. Case 286/86, Ministère public v Gérard Deserbais [1988] ECR 4907. 89 The relationship between the FAO/WHO Codex Alimentarius and EU food law is discussed in more detail in Chapter 4 below. 88

(C) MacMaolin Ch2

9/2/07

15:15

Page 44

44 Free Movement of Food in the EU In Canadane, when examining whether there was a ‘substantial difference’ between two forms of cheese made in different ways and with different ingredients, the Advocate General, in his Opinion, accepted that this possible exception to the mutual recognition of generic names was not clearly demarcated in these two judgments.91 The criteria determining substantial difference between national products and those imported goods that were likely to mislead consumers had not, he stated, been properly defined.92 The Smanor judgment mentioned consumer expectations in the importing State, the provisions of the FAO/WHO Codex Alimentarius and the national law of the importing State. In Deserbais only the method of production and composition of the product were referred to. Furthermore, it was noted, no order of priority was laid down for the criteria and, if applied to a particular product in different orders, could produce conflicting conclusions. Nor was any indication given as to the degree of difference that must exist between the imported and national products for this difference to be considered so substantial that additional labelling will not suffice. In Commission v France (foie gras), it was claimed that French national rules introduced in 1993 on preparations using foie gras as a base were contrary to Article 28 EC as they did not put in place any mutual recognition provision for similar products coming from other Member States.93 France had argued that the rules were necessary in order to enable consumers to identify the true nature of the products that they were purchasing. Rejecting this contention with the usual labelling panacea, the Court did recognise the possible effects of its earlier decision in Deserbais here. Substantial difference in composition or production method between products could entitle the Member State to oblige that an alternative description be used on imported varieties. However, this was qualified with the further condition that this test of difference level would not be satisfied merely by the fact that this alternative variety did not wholly conform to the requirements laid down in domestic rules. While the Court has introduced the possibility that a ‘substantial difference’ between products may enable Member States to prohibit the sale of the variety which their consumers are not accustomed to, this test of difference remains unclear and, in any case, is a very difficult one to satisfy. Even where such difference may exist, it will always be near impossible for a Member State to justify the introduction of a prohibition on the sale of a product lawfully marketed in another Member State for consumer protection purposes. It is only where substantiated claims about the serious detrimental health effects of a foodstuff can be made that any such action may be tolerated. 90 Commission interpretative communication on the names under which food products are sold. [1991] OJ C 270/2. 91 Opinion of Advocate General Ruiz-Jarabo Colomer in Case C-317/1995, Canadane Cheese Trading AMBA and Adelfi G Kouri Anonymos Emoriki Kai Viomichaniki Etaireia v Hellenic Republic [1997] ECR I-4681. The case never proceeded to full Court determination. 92 For further discussion see C Lister, ‘The Naming of Foods: The European Community’s Rules for Non-Brand Food Product Names’ [1993] European Law Review 179. 93 Case C-184/1996, Commission v France (foie gras) [1998] ECR I-6197.

(C) MacMaolin Ch2

9/2/07

15:15

Page 45

2.2 Measures Equivalent to Quantative Restrictions 45 2.2.7 Protecting Human Health under Article 30 EC It is quite clear from the wording of Article 30 EC that those who drafted the Treaty envisaged that exceptions to Article 28 EC would not only be necessary in some circumstances, but could even be vital to ensuring the health of humans, animals or plants. They had probably not expected that the remit of Article 28 EC would spiral out of control in the manner in which it has. More importantly than that, it was presumably not anticipated that the Court of Justice would limit the real effect of the Article 30 EC exceptions in such a manner as to render their existence almost meaningless. It has been made far too difficult for Member States to argue that a national measure escapes the Article 28 EC prohibition as it is necessary for human health preservation. The Court has created a very narrow set of circumstances in which Article 30 EC can be successfully invoked. The case law illustrates that while the Community courts have allowed their own institutions to act on a precautionary basis where uncertainty over the safety of a foodstuff exists, it has always been much more reluctant to allow the Member States to act in such a manner, although recent developments, probably in light of the post-BSE atmosphere of panic, indicates a slight shift in favour of Member State autonomy in this regard. Article 30 EC states: The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.

Right through from the earliest founding case law, such as the decision in Cassis, to the challenging of German beer purity rules and those on using substitutes for milk, the Court has persistently rejected Member States’ pleas that their national rules are necessary for the protection of human health. While this was not surprising in Cassis, where the argument put forward by the Member State in this regard was weak, it is unfortunate that the Court has refused to consider the improvement of health as a legitimate Article 30 EC claim—once it has been established that the measure is not a disguised restriction on trade—such as those made in both the beer and the milk substitute cases. It was never intended that the Article 30 EC exception to the prohibition on measures equivalent to quantitative restrictions on imports would relate to dangers to human health only. The preservation and improvement of health is of at least equal importance. A clear example of the manner in which the Community courts will not permit the Member States to protect the health of their people was seen in Commission v Germany, where the Court examined whether Article 28 EC was breached by a ban on the marketing of some meat products.94 German rules prohibited the marketing 94

Case 274/1987, Commission v Germany (meat products) [1989] ECR 229.

(C) MacMaolin Ch2

9/2/07

15:15

Page 46

46 Free Movement of Food in the EU of ‘meat products’ where these contained ingredients other than pure meat, subject to some exceptions. There was no dispute as to the restrictive effect that the rules had on Community trade. Germany contended, however, that the rules were necessary in the interests of public health protection, justifiable under Article 30 EC, and mandatory requirements relating to consumer protection, fair trading and the common agricultural policy. The rules were applicable without distinction to national and imported products. The Court proceeded to examine the protection of public health justification available under Article 30 EC for national rules that act contrary to Article 28 EC. It was first pointed out that the Article 30 EC exception could only be used where it was necessary for the protection of human life and health, and only if that objective could not be achieved by measures less restrictive on intra-Community trade.95 Germany argued that the measures in question were necessary to ensure that humans received a sufficient intake of essential nutrients from the food they consume, in this case proteins in meat. The Court used two German reports of 1980 and 1984 to repudiate the necessity of the German measures in achieving such an aim as they demonstrated that even where protein intakes were lower than the recommended level, in particular amongst young people, these levels posed no threat to human health. The reports had also expressed concern about increased meat consumption, in particular stating that additional intake of purine, cholesterol and saturated fatty acids from these foodstuffs could be harmful to human health. Finally, Germany argued that vegetable proteins have a lower nutritional value than animal proteins. Here that Court responded by stating that a Member State could not invoke public health grounds in order to prohibit the importation of a product by arguing that its nutritional value is lower than another product available on the market.96 The fact that an imported product has a lower nutritional value does not mean that it poses any real threat to human health. The contested prohibition could not thus be justified on any grounds relating to the protection of human health within the meaning of Article 30 EC. The Member State was seeking to ensure that its consumers receive a satisfactory level of nutrients, in this case protein, from the food that they eat. The Court found that this was not a legitimate use of Article 30 EC. This aspect of the Treaty could not be used to improve human health. It was rather designed to prevent threats to human health from specific and determinable ill effects, usually due to either contamination or disease. A further example of this approach to human health protection is seen in Bellamy, where it was held that national rules prohibiting the marketing of bread with a high salt content was contrary to Article 28 EC.97 Despite concerns about the detrimental effects on human health of a high intake of salt in diets, the rules were not justifiable under the terms of Article 30 95 See Case 104/1975, De Peijper [1976] ECR 613; Case 261/1985, Commission v UK (milk and cream) [1988] ECR 547. 96 See also Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 97 Case C-123/2000, Criminal proceedings against Christina Bellamy and English Shop Wholesale SA [2001] ECR I-2795.

(C) MacMaolin Ch2

9/2/07

15:15

Page 47

2.2 Measures Equivalent to Quantative Restrictions 47 EC as the products in question were lawfully manufactured and marketed in another Member State.98 In the Commission v Germany beer purity case the national rules on additive usage in beer production presented a slightly more complex problem for the Court than the compositional requirements case.99 It had previously been held that where there are scientific uncertainties about adverse health effects, it is for the Member States, in the absence of harmonisation, to decide what degree of health protection to provide, taking appropriate account of the free movement of goods.100 Community law does not preclude Member States adopting legislation whereby the use of additives is subject to prior authorisation.101 However, it was found here that the application to imported products of a prohibition on the use of additives that are authorised in the Member State of production but prohibited in the Member State of importation is permissible only insofar as it complies with the requirements of Article 30 EC. Previous case law indicated that such prohibitions had to be restricted to that which is absolutely necessary to secure the protection of public health.102 This could not be the case where the scientific evaluations indicate that the additive in question does not present a risk to public health and meets a real need, especially a technical one.103 The German rules excluded the use of all additives authorised in the other Member States. They also prevented importers from accessing a procedure whereby they could obtain authorisation for the use of a specific additive in the manufacture of beer. This was required by Community law, particularly the principle of proportionality.104 The German scientific evidence offered referred to the risks inherent in the ingestion of additives in general. Given that beer was consumed in such large quantities in Germany, it was felt necessary to prohibit the use of additives in its production to reduce consumers’ overall consumption of additives in their diet. It was also claimed that there was no technological need to use additives in beer. Both arguments were again rejected. The first was thrown out for obvious reasons: it was, superficially at least, a weak point of contention, especially when considering that some of the additives prohibited were permitted to be present in other types of food and drink. The second was rejected because the Court found 98 The health benefits of reducing salt intake in the diet are disputed. For further discussion on the potential detrimental effects of a high salt diet on human health, in particular increased risk of strokes and heart attacks, see FJ He and GA MacGregor, ‘Effect of Modest Salt Reduction on Blood Pressure: A Meta-analysis of Randomized Trials. Implications for Public Health’ (2002) 16 Journal of Human Hypertension 761; MH Alderman, ‘Salt, Blood Pressure and Human Health’ (2000) 36 Hypertension 890. For an alternative view, although based on less rigorous research, see NA Graudal et al, ‘Effects of Sodium Restriction on Blood Pressure, Renin, Aldosterone, Catecholamines, Cholesterols and Triglyceride’ (1998) 279 Journal of the American Medical Association 1383. 99 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. 100 See, in particular, Case 174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445. 101 Ibid; Case 247/1984, Criminal proceedings against Léon Motte [1985] ECR 3887; Case 304/84, Criminal proceedings against Claude Muller [1986] ECR 1511. 102 Ibid. 103 Ibid and Case 178/1984, Commission v Germany (bier) [1987] ECR 1227, para 44. 104 Case 304/1984, Criminal proceedings against Claude Muller [1986] ECR 1511.

(C) MacMaolin Ch2

9/2/07

15:15

Page 48

48 Free Movement of Food in the EU that the concept of technological need was to be assessed in light of the raw materials utilised, bearing in mind the assessment made by the authorities of the Member State where the imported beer was produced and marketed, and the available scientific data. The fact that German production methods clearly demonstrated that additives need not be used in the manufacture of beer was seen as irrelevant, as this did not prove that the additives could not serve a technological function. What then would be the case for beers produced using only the permitted raw materials but still containing additives? This question was not answered, despite the fact that the German method of beer manufacture was such as not to require additive use. The German rules on the use of additives in the manufacture of beer were, however, also held to be contrary to Community rules on the free movement of goods, being disproportionate to the aim pursued and not justifiable under the terms of Article 30 EC. The decision on the invocation of Article 30 EC in the German beer purity case clearly demonstrates the stance that the Court has adopted in relation to the use of additives in food. While additives are discussed in more detail in Chapter 5 below, what can be noted here is that ‘technological need’ does not mean that the product cannot be satisfactorily manufactured without use of the additive, as it might suggest. Technological need also includes making a product last longer (although not necessarily significantly longer), planting the taste of an ingredient into a foodstuff that it does not possess, or making a food product look as though it contains an ingredient it does not contain.105 Using ingredients that deceive the consumer into believing that they are buying something that they are not is considered by the Court to be a ‘technological need’.106 As we have seen, in Commission v France the respondent Member State submitted two arguments to support its assertion that a prohibition on the marketing of milk substitutes was necessary for health preservation reasons. These were: (i) decreased nutritional value; and (ii) the harmful effects of consuming milk substitutes. Both were rejected. The nutritional value argument was rejected on the grounds that a Member State may not invoke public health grounds in order to prohibit the importation of a product by arguing that its nutritional content is lower, or that its fat content is higher, than another product already available on the market in question—the mere fact that the imported product possesses these characteristics not in itself substantiating any claim that there is a danger posed to human health.107 This rejection was supported by the fact that there were other products available on the French market which also had a lower nutritional value or which were composed of the same fats as milk substitutes yet there was no ban on the marketing of these products. This assertion, of course, fails to take account 105

Case C-51/1994, Commission v Germany (sauces and pastries) [1995] ECR I-3599. The Court will allow Member States to ban the use of additives in some circumstances, even where their use is allowed in other Member States: Case 53/1980, Officier van Justitie v Koninklijke Kaasfabriek Eyssen BV [1981] ECR 409. This is discussed in more detail in Chapter 5 below. For further discussion on this see also Weatherill, note 22 above, p 43. 107 Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793, para 15. 106

(C) MacMaolin Ch2

9/2/07

15:15

Page 49

2.2 Measures Equivalent to Quantative Restrictions 49 of the fact that milk is a nutritional product, being a rich source of calcium, while these other foodstuffs to which the Court refers are not necessarily consumed for their nutritional value. Other aspects of the health protection argument were finally quashed when the Court accepted the Commission’s argument that milk products themselves also pose risks to people suffering from certain diseases and that there was scientific disagreement as to the actual and potential dangers to human health posed by the consumption of animal and vegetable fats. Again, labelling would be sufficient to inform the consumer as to the nature of the product, enabling them to make any decision on consumption for themselves. In Zoni, the Article 30 EC argument presented was immediately rejected, Italy being unable to offer any evidence that the pasta type prohibited by national law could be harmful to human health, despite claims that pasta containing wheat often contained chemical additives and colourants to alter its organoleptic properties to make it appear more like durum wheat pasta.108 The case law of the Court of Justice makes it clear that Article 30 EC cannot be used by Member States to justify national measures designed to improve the standard of their inhabitants’ health, in particular through improving the nutritional content of food. National measures that inhibit the free movement of goods may only be justified on health protection grounds where there is a clear danger posed through, for example, contamination or severe adverse reaction to ingredients or a particular combination of ingredients. However, the Court has also been reluctant to accept arguments based on this approach where there is not sufficient scientific evidence to support prohibitive national measures that inhibit the free movement of food in some way. This is now central to much EU food law. Essentially, the Community and the Member States do now have licence to act where they believe that there is a danger posed to human health by a particular foodstuff in some circumstances. Assessing the nature and type or level of evidence that is required to support any such measures is key to ascertaining the limits within which those who wish to may act.

2.2.8 National Authorisation Procedures One aspect of national law that has come under increased court scrutiny in recent years has been the application of national authorisation procedures for the marketing of foodstuffs. It is this body of case law that has indicated the potential willingness of the Court to allow, in some circumstances, national rules designed to protect human health to stand. However, it should also be noted that this relates only to potential dangers posed. Health preservation remains firmly outside the scope of the Article 30 EC exception.

108 Case 90/1985, Criminal proceedings against Zoni [1988] ECR 4285. See also Case 407/1985, Glocken GmbH and Kritzinger v USL Centro-Sud and Provincia autonoma di Bolzano [1988] ECR 4233.

(C) MacMaolin Ch2

9/2/07

15:15

Page 50

50 Free Movement of Food in the EU In Commission v Italy, for example, the Court examined the compatibility of national rules, which required that sports foodstuffs be authorised for use prior to marketing, and that the manufacturer pay resultant administrative costs to the national authorities, with Article 28 EC.109 The Commission was alerted by a British manufacturer of such foods, in particular energy bars and hydrating drinks, who had experienced difficulty marketing their products in Italy. The respondent State argued that the national authorisation procedure at issue was necessary to protect human health and was therefore justifiable under the terms of Article 30 EC. The Court accepted that, in principle, the national rules were not contrary to Community law, once certain conditions could be satisfied.110 Such rules would, however, have to be justifiable under the terms of Article 30 EC or one of the Cassis and subsequent case law mandatory requirements. According to the case law, it would be for the national authorities to demonstrate that their rules are necessary in order to meet one of the Article 30 EC public protection derogations. In particular, it would have to be demonstrated that the marketing of the products in question poses a serious risk to public health and that the rules are in conformity with the principle of proportionality.111 The Court found that these elements were not demonstrated here. In particular, Italy had failed, according to the Court, to explain on what scientific data or medical reports its decision was based, and it had not provided even general information on the nature of the alleged risks, despite requests from the Commission for such information. Furthermore, it was not made clear what the link was between the procedure in question and the alleged risk to public health. Nor were reasons given as to why this method of protection rather than another was chosen, which would have evidenced proportionality to the aims pursued. The Court also accepted that other, more proportionate measures could instead have been used to achieve the same objective, such as providing notification to the relevant authority, together with transmission of a model of the labelling and, if necessary, evidence of the accuracy of the factual data appearing on this label.112 The Italian procedure was thus contrary to Article 28 EC and not justifiable by the terms of Article 30 EC. In Greenham and Abel the Court examined French legislation which prohibited the sale of foodstuffs containing non-authorised chemical products.113 The defendants were prosecuted before the national courts for selling foodstuffs containing added co-enzyme Q10, which was not authorised for human consumption 109

Case C-270/2002, Commission v Italy (sports supplements) [2004] ECR I-1559. See also Case C-344/1990, Commission v France (cheese nitrate) [1992] ECR I-4719, para 8; Case C-24/2000, Commission v France (fortified foods-‘Red Bull’) [2004] ECR I-1277, paras 25–27. 111 Case 227/1982, Criminal proceedings against Leendert van Bennekom [1983] ECR 3883, para 40; Case C-358/1995, Tommaso Morellato v Unità sanitaria locale (USL) n 11 di Pordenone [1997] ECR I-1431, para 14; Case C-14/2002, ATRAL SA v Belgium [2003] ECR I-4431, para 67; Case C-420/2001, Commission v Italy (caffeine energy drinks) [2003] ECR I-6445, para 30. 112 Case C-77/1997, Österreichische Unilever GmbH v Smithkline Beecham Markenartikel GmbH [1999] ECR I-431, para 35; Case C-221/2000, Commission v Austria (health claims) [2003] ECR I-1007, paras 49 and 52. 113 Case C-95/2001, Criminal proceedings against Greenham and Abel [2004] ECR I-1333. 110

(C) MacMaolin Ch2

9/2/07

15:15

Page 51

2.2 Measures Equivalent to Quantative Restrictions 51 by the relevant French procedures. The product (juice) also contained vitamins in quantities exceeding recommended daily allowances and safety limits. The defendants argued that the foodstuffs in question were already lawfully marketed in other Member States. The Court was asked whether Articles 28 EC and 30 EC were to be interpreted as prohibiting a Member State from preventing the free movement and marketing of a food supplement lawfully sold in another Member State, in this case due to the fact that the products had not received domestic marketing authorisation. The Court found that national authorisation procedures could be justified if certain conditions were met. These were: (i) that the rules make provision for a procedure enabling economic operators to have a nutrient included on the national list of authorised substances, this procedure being readily accessible and capable of being completed within a reasonable period of time, and if leading to a refusal, the decision must be open to challenge before the courts;114 and (ii) that an application to include a nutrient on the national list of authorised substances may be refused by the competent national authorities only if the substance concerned poses a genuine risk to human health.115 It is for the Member States, in the absence of harmonisation and where there is uncertainty in the scientific research, to decide on the level of protection of human health they wish to ensure and whether to require prior authorisation for the marketing of foodstuffs, taking into account the requirements of the free movement of goods.116 That discretion is to be particularly wide where scientific uncertainty persists as regards the use of certain nutrients which are not as a general rule harmful in themselves but which may have harmful effects if taken in excess.117 However, the Court found here that in exercising this discretion in relation to the protection of public health in such circumstances, the Member States must comply with the principle of proportionality. They must exercise their discretion by choosing only such rules as are actually necessary and proportionate to meet the objective pursued. They must not have been able to achieve the aim by imposing less restrictive measures.118 The national authorities must substantiate any measures adopted that they seek to justify under the terms of Article 30 EC. Such a justification must be based on a case-by-case consideration, taking account of national nutritional habits and international scientific research.119 Such research should demonstrate that the rules in question were necessary to give effective protection to human health. A detailed risk assessment is thus required to justify any prohibitive national 114 Case C-344/1990, Commission v France (cheese nitrate) [1992] ECR I-4719, para 9; Case C-24/2000, Commission v France (fortified foods-‘Red Bull’) [2004] ECR I-1277, para 26. 115 Case C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693, para 46. 116 Ibid, para 42. 117 Ibid, para 43. See also Case 174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445, para 17. 118 Case C-95/2001, Criminal proceedings against Greenham and Abel [2004] ECR I-1333, para 39; also Case C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693, para 45; Case 174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445, para 18. 119 Case C-95/2001, Criminal proceedings against Greenham and Abel [2004] ECR I-1333, para 40.

(C) MacMaolin Ch2

9/2/07

15:15

Page 52

52 Free Movement of Food in the EU measure. The Court found that a decision to prohibit the marketing of a fortified foodstuff, which was described as being ‘the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States’, could thus only be adopted where the alleged risk to public health is sufficiently established on the basis of the latest scientific data available at the time of adopting the contested measure.120 Where there is still uncertainty as to the level or nature of the potential risk posed, the Member State may, in accordance with the precautionary principle, take protective measures without having to wait until the existence and/or gravity of those risks are fully demonstrated.121 The assessment must not be based on purely hypothetical considerations.122 It is for the national court to determine whether the legal and factual circumstances demonstrate that any prohibition, such as that under examination here, satisfies the requirements of Community law in order for such a restriction on the free movement of goods to be justified. Any such national measures must first satisfy the requirements that they are accessible and have an appeals mechanism, and that decisions must follow a detailed and reliable risk assessment.123 In Commission v France,124 national rules on the marketing of food supplements and fortified foods which prohibited the sale of such products unless they had received prior authorisation, were examined for compatibility with Article 28 EC. There were three issues here to which the Commission objected. First, it was claimed that the national rules made no provision for mutual recognition of foodstuffs lawfully manufactured or marketed in other Member States to which unauthorised nutrients had been added. Second, the lack of a simplified authorisation procedure was contrary to Community law. Third, there was no justification for refusing to include the unauthorised nutrients at issue on the positive list on public health protection grounds, as had been contended. It was not disputed that the French legislation constituted a measure of equivalent effect to a quantitative restriction on imports. It was not in principle contrary to Community law either, provided that certain conditions could be satisfied, these being the existence of a readily accessible authorisation procedure, the potential to appeal any refusal to grant authorisation and that refusals only occur where strictly necessary to protect human health.125 The accessibility requirement can be satisfied if the procedure is expressly provided for in a measure of general application which is binding on the national authorities.126 The Member State had itself recognised in a reply to a reasoned opinion of the Commission that the 120

Case C-95/2001, Criminal proceedings against Greenham and Abel [2004] ECR I-1333, para 42. Case C-157/1996, The Queen v National Farmers’ Union and others [1998] ECR I-2211, para 63. 122 Case C-236/2001, Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others [2003] ECR I-8105; Case C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693, para 49. 123 Case C-95/2001, Criminal proceedings against Greenham and Abel [2004] ECR I-1333, para 50. 124 Case C-24/2000, Commission v France (fortified foods-‘Red Bull’) [2004] ECR I-1277. 125 Case C-344/1990, Commission v France (cheese nitrate) [1992] ECR I-4719, paras 8 and 9; Case C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693, paras 44 and 46. 126 Paragraph 37. See also Case 176/1984, Commission v Greece (beer) [1987] ECR 1193, para 41. 121

(C) MacMaolin Ch2

9/2/07

15:15

Page 53

2.2 Measures Equivalent to Quantative Restrictions 53 national legislation required clarification in this regard. In order to satisfy this, national legislation should specify the information that is to be included on the application and describe the procedure for investigating such an application. The national procedure must also be capable of being completed within a reasonable time. The Commission claimed here that the applicable provisions did not fix any time limit for this. However, key to the findings here was the fact that the application for authorisation to market the drink ‘Red Bull’ had been lodged with the national authorities seven months before there was any acknowledgement of its receipt. More than two years had passed before the applicant was notified of the decision to reject the application. This, and other similar examples, led the Court to determine that such applications were not being dealt with within a reasonable period of time. Nor were the applications being considered by a procedure that was sufficiently transparent as regards the possibility of challenging a refusal to authorise before the courts. The complaint about the absence of a simplified application procedure was thus considered to be well-founded on the evidence presented. The third complaint, it will be remembered, was that there were no valid public health protection grounds for justifying the refusal to include certain nutrients on the authorised list. The Court reiterated that it is for the Member States, in the absence of harmonisation, and where there is uncertainty in the current state of scientific research, to decide on the level of human health protection that they wish to ensure, and whether to require prior authorisation for the marketing of foodstuffs, taking into account the free movement of goods within the Community.127 The discretion allowable here is to be particularly wide where it can be demonstrated that there is still uncertainty in the current state of scientific research as to certain substances, such as vitamins, which are not generally harmful in themselves but may have harmful effects if taken in excess.128 However, in exercising this discretion, the Member States must adhere to the principle of proportionality, confining any national measures taken in this regard to those which are necessary to safeguard public health or to satisfy mandatory requirements, such as consumer protection.129 Furthermore, it was stated that since Article 30 EC provides for an exception to the free movement of goods, which must be construed restrictively, it is for the national authorities which invoke it to show in each case that, in the light of national nutritional habits and the results of international scientific research, their rules are necessary to give effective protection. In particular, they must show that the marketing of the products in question poses a real risk to public health.130 A prohibition on the marketing of foodstuffs to which nutrients have been added must therefore be based on a detailed risk assessment by the

127 Case 174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445, para 16; Case C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693, para 42. 128 Paragraph 50. See also Sandoz, ibid, para 17; Commission v Denmark, ibid, para 43. 129 Paragraph 52. See also Sandoz, ibid, para 18; Commission v Denmark, ibid, para 45. 130 Paragraph 53. See also Commission v Denmark, ibid, para 46.

(C) MacMaolin Ch2

9/2/07

15:15

Page 54

54 Free Movement of Food in the EU Member State invoking Article 30 EC.131 This assessment must demonstrate that the risk is sufficiently well established by the latest scientific assessments. Where the assessments demonstrate scientific uncertainty, the Member State may invoke the necessary protective measures without having to wait for the existence or gravity of those risks to be fully demonstrated.132 France argued that consumers may be encouraged to consume numerous vitamin-enriched foods, augmenting their normal intake from a varied diet, stating that the French population, for the most part, obtains a sufficient intake of most vitamins from their normal diet. There was therefore no nutritional need for nutrients to be added to the foodstuffs concerned. The Court accepted that where there is scientific uncertainty, the criterion of nutritional need of the population of a Member State can play a role in the risk assessment of these fortified foods.133 However, it was also stated that the absence of such a need cannot by itself justify a total prohibition on the basis of Article 30 EC.134 Given that the decision to prohibit was based on this reasoning, the Court found that the assessment was not sufficiently detailed to satisfy the exceptions to Article 28 EC available under Community law, both Article 30 EC and the related case law. Lack of nutritional benefit is not sufficient to justify a prohibition, on the basis of Article 30 EC, on marketing foodstuffs lawfully manufactured and/or marketed in other Member States. Establishing the fact that some people might suffer digestive problems if they exceed a maximum recommended vitamin intake does not constitute a sufficiently detailed assessment.135 The Court did, however, accept the French argument about the energy drink ‘Red Bull’. France could of course, in the absence of harmonisation, decide how best to protect its population. It would, however, have to show that the prohibition on marketing energy drinks containing caffeine exceeding a certain limit was both necessary and proportionate for this purpose.136 The Scientific Committee on Human Nutrition had already stated that there were negative effects in having certain nutrients such as taurine (sulphur containing aminoacid) and glucurunolactone (a naturally occurring chemical compound produced by the metabolisation of glucose) in drinks. In such circumstances, the Court stated, it would be for the Commission to demonstrate why the French Government’s argument based on that assessment would not suffice to justify the refusal to authorise the sale of these energy drinks. The Court concluded that the Commission had not demonstrated this and therefore the complaint about the 131 Paragraph 54. This could potentially mean that if the risk assessment justifies the measure then similar measures should be taken throughout the EU on the basis of the precautionary principle. This is discussed in more detail in Chapter 5 below. 132 Paragraph 56. See also Case C-157/1996, The Queen v National Farmers’ Union and others [1998] ECR I-2211, para 63. 133 Paragraph 59. 134 Paragraph 60. See also Case C-192/2001, Commission v Denmark (enriched foodstuffs) [2003] ECR I-9693, para 54. 135 Paragraph 65. 136 Paragraph 69. See also Case C-420/2001, Commission v Italy (caffeine energy drinks) [2003] ECR I-6445, paras 30 and 31.

(C) MacMaolin Ch2

9/2/07

15:15

Page 55

2.2 Measures Equivalent to Quantative Restrictions 55 prohibition on marketing energy drinks with a high caffeine content and added taurine and glucurunolactone should be rejected. Finally, on the issue of consumer protection, the Court found that appropriate labelling, informing consumers about the nature, ingredients and characteristics of fortified foodstuffs, could enable consumers who risk excessive consumption of a nutrient added to those products to decide for themselves whether or not to take them.137 The recent case law on the compatibility of national authorisation procedures with Article 28 EC raises a number of interesting points about the direction EU food law is taking in this area. Primarily, it is quite clear that Member States may have such procedures in place. Their existence can be justified by Article 30 EC, provided that they can be considered to be ‘accessible, independent and transparent’. Decisions must be open to appeal by aggrieved applicants. Allowing such procedures to exist indicates a notable softening in the Court’s willingness to accept Member States’ justifications for continuing to impose measures equivalent to quantitative restrictions on intra-Community trade.138 National authorisation procedures inhibit trade by adding expense to the marketing process, and by increasing the length of time it takes to get the foodstuff onto the marketplace. Despite this, they are allowable once they do not overly inhibit market access. Compare this, for example, with the decision made on the German beer purity rules. Here, the Member State clearly demonstrated that the use of additives in the production of beer was not necessary. Additive use presents a danger to human health.139 The Member State did not prohibit their use, only the marketing of beverages containing additives as ‘bier’. Article 30 EC justifications put forward were rejected. Now, following the decisions in Greenham and Abel and Commission v France (Red Bull), the presentation of some evidence that adding nutrients to food may present a danger suffices to justify the measure that is equivalent to a quantitative restriction under Article 30 EC. This measure may even be an outright prohibition on marketing—not previously allowable by the Court in such circumstances. Formerly, a clear danger arising out of contamination or disease had to exist before any national trade-inhibiting measure could be justified by the Article 30 EC exception. What has brought about this change in the Court’s handling of Article 30 EC claims? It is suggested that there is greater acceptance by all the Community institutions since the BSE crisis that the protection of human health must be placed at the top of the food law agenda to both regain and retain consumers’ confidence. This is discussed in more detail in Chapter 5. 137

Paragraph 75. Similarly, acceptance of Article 30 EC justifications have also been apparent more recently in Schwarz, where Austrian rules prohibiting the sale of unwrapped sweets from vending machines were deemed justifiable on public health grounds. Case C-366/2004, Georg Schwarz v Bürgermeister der Landeshauptstadt Salzburg [2005] ECR I-10139. 139 See, for example, JP Groten et al, ‘An analysis of the possibility for health implications of joint actions and interactions between food additives’ (2000) 31 Regulatory Toxicology and Pharmacology 77; and DO Carpenter, K Arcaro and DC Spink, ‘Understanding the Human Health Effects of Chemical Mixtures’ (2002) 110 Environmental Health Perspectives 25. 138

(C) MacMaolin Ch2

9/2/07

15:15

Page 56

56 Free Movement of Food in the EU 2.2.9 Common Agricultural Policy Justification Finally, another justification for the existence of national rules acting contrary to Article 28 EC that has been put forward by Member States, with equally limited success, is that the measure in question helps to promote the aims and objectives of the Common Agricultural Policy. In Commission v Germany it was contended that the contested ban on the importation of certain meat products was necessary to meet the requirements of the Common Agricultural Policy, particularly the aim of stabilising the market pursued by the common organisations of the markets in beef, veal and pig-meat.140 This argument was not accepted, the Court finding, as it had done previously,141 that once the Community has established a common market organisation in a particular sector, Member States must refrain from taking any unilateral measure, even if that measure is likely to support the common policy. It was stated that it was also clear from these judgments that, even if they support a common Community policy, such measures must not conflict with one of the fundamental principles of the Treaty, in this case the free movement of goods, unless they are justified by reasons that are recognised by Community law. This was not found to be the case here. Similarly, in Commission v France the assertion that a national prohibition on the sale of milk substitutes was consonant with the aims pursued by the Common Agricultural Policy was not accepted by the Court because national measures such as those at issue could not act contrary to the fundamental principle of the free movement of goods in any circumstances, unless justified by reasons recognised by Community law.142 In Commission v Germany the Court,143 citing Commission v France 144 and Centro-Sud,145 reiterated that once the Community has established a common market organisation in a particular sector, the Member States must refrain from taking any unilateral measure that consequently falls within the competence of the Community. It was for the Community and not the Member State to seek a solution to any problem in the context of the Common Agricultural Policy. Even where supporting a common Community policy, national measures may not conflict with one of the fundamental principles of the Community unless justifiable by reasons organised by Community law.146

140

Case 274/1987, Commission v Germany (meat products) [1989] ECR 229. Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793; Case 407/1985, Glocken GmbH and Kritzinger v USL Centro-Sud and Provincia autonoma di Bolzano [1988] ECR 4233. 142 Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 143 Case 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021. 144 Case 216/1984, note 143 above, paras 18 and 19. 145 Case 407/1985, Glocken GmbH and Kritzinger v USL Centro-Sud and Provincia autonoma di Bolzano [1988] ECR 4233, para 26. 146 Case 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021, para 20. 141

(C) MacMaolin Ch2

9/2/07

15:15

Page 57

2.3 Taxes and Duties on the Movement of Food 57

2.3 TAXES AND DUTIES ON THE MOVEMENT OF FOOD

As we have seen, Article 28 EC seeks to promote the free movement of goods by limiting the circumstances in which Member States will be permitted to have domestic consumer protection or human health protection rules in place. In the remaining part of this chapter we show that Article 25 EC, on customs duties and measures of equivalent effect, and Article 90 EC, on internal taxation that discriminates in favour of domestically produced goods in some way, seek to promote the free movement of goods by ensuring, primarily, that imports are fully able to compete on price. By illegitimising charges for border checks being passed on to importers, Article 25 EC removes an additional cost of importation. By prescribing that similar amounts of tax be charged on similar products, Article 90 EC effectively removes the last remaining possibility of Member States protecting domestic production in an indirect or disguised manner. 2.3.1 Internal Taxation on Imported Foodstuffs Article 90 EC (ex 95) states: No Member State shall impose, directly or indirectly, on the products of other Member States any internal taxation of any kind in excess of that imposed directly or indirectly on similar domestic products. Furthermore, no Member State shall impose on the products of other Member States any internal taxation of such a nature as to afford indirect protection to other products.

In relation to the free movement of food, this has come to mean that national taxation systems levying a lower rate of tax on foods produced in their territory in abundance, and a higher rate on foods produced widely, contravene the Treaty. The most obvious examples of such discriminatory taxation regimes are those where imported alcoholic drinks are taxed at a higher rate than those produced domestically, for example charging a high rate of tax on wine which is not widely produced in the State of taxation, as opposed to charging a relatively low rate of tax on beer which is produced throughout the same State. In any Article 90 EC case, the first issue that must be examined is whether the products on which the different rates of tax are charged are in competition with each other, because, of course, Member States are perfectly entitled to charge different rates of tax on different types of products that are not interchangeable with each other. The process of determining whether apparently different types of goods are competing in the same market is not always clear-cut. For example, while wine and beer both form part of the market in alcoholic beverages, it is not so easy to establish that they share enough of the same characteristics to be deemed interchangeable with each other when it comes to consumer preferences. In other words, would the consumer with a preference for wine be willing to purchase beer instead, if it were more competitively priced? Similarly, bananas and apples may

(C) MacMaolin Ch2

9/2/07

15:15

Page 58

58 Free Movement of Food in the EU both be fruit, but for Article 90 EC to be applicable it must first be ascertained whether those who tend to consume the soft banana that comes in its own wrapping would also be keen on hard apples that require washing prior to consumption. In Commission v France a national taxation system that charged the same purchase tax on cereal-based spirits (whiskey) as fruit-based spirits (brandy) but charged a manufacturing tax on the former only was examined for compatibility with Article 90 EC.147 There was no significant production of cereal-based spirits in France. After establishing that the two categories of spirit shared sufficient common features, most notably the occasions on which they are likely to be consumed, the Court determined that they were in at least partial competition with each other. The fact that the two types of spirit were deemed interchangeable, coupled with the fact that domestically produced spirits were more likely to come within the more favourable tax category than imported spirits, meant that the tax system applied by France here was incompatible with Article 90 EC. The fact that another domestic product, aniseed spirits, also fell within the disadvantaged category did not mean that the system was not protective in nature. Nor was this disproved by the evidence presented to the Court illustrating that the market share of whiskey had increased in spite of the tax disadvantage that it suffered. Similarly, wine and beer have been deemed to be in competition with each other for the purpose of Article 90 EC examination.148 The Court has considered that the two beverages are capable of meeting identical needs. It was accepted that beer was in competition with wines that have an alcohol content of nine per cent, based on the fact that these are the most accessible to the public, being the lightest and cheapest varieties. Given that wine was subjected to a much higher rate of tax than beer in the United Kingdom, that Member State was deemed to have in place a system of taxation which subjected wine imported from other Member States to an additional tax burden so as to afford protection to domestic beer production contrary to Article 90 EC. It is not always clear whether an unfair charge imposed by a Member State on an imported food product may fall within the type prohibited by Article 25 EC on the one hand or Article 90 EC on the other. The consequences of this can be very important when determining what the fate is to be when such a charge is found to be contrary to either Treaty prohibition. As discussed below, Article 25 EC contains an absolute prohibition. Any such charges, no matter how small, are contrary to the Treaty. The practice of imposing such charges must cease. However, a system of taxation that favours a domestic food product over an import with which it is interchangeable may continue, even where found to be contrary to Article 90 EC. The taxation need not stop, it just has to be modified to remove the effect which has been adjudged to be protective.

147 148

Case 168/1978, Commission v France (spirit tax) [1980] ECR 347. Case 170/1978, Commission v UK (wine and beer tax) [1983] ECR 2265.

(C) MacMaolin Ch2

9/2/07

15:15

Page 59

2.3 Taxes and Duties on the Movement of Food 59 In Co-frutta it had to be determined whether an Italian tax on banana consumption was caught by the prohibition set down in Article 25 EC or Article 90 EC.149 While Italy did produce some bananas, home-produced bananas constituted a very small proportion of the total tonnage consumed there (150 tonnes out of 357,500 in 1985). However, similar taxes were charged on other tropical foodstuffs sold in Italy, such as coffee and cocoa, as well as on other products including spirits, beer, sugar and margarine. The Court found that the essential feature of a charge having an effect equivalent to a customs duty that distinguishes it from an internal tax is the fact that the former is borne solely by an imported product. The latter is borne by both imported and domestic products. However, it had also been recognised that where a charge is borne by a product imported from another Member State and there is no identical or similar domestic product available, then this charge will be considered to be internal taxation within the meaning of Article 90 EC if it relates to a general system of internal taxation applied systematically to categories of products, irrespective of the origin of those products. This tax at issue here was deemed to form part of such a general domestic system. Once it had been established that it was Article 90 EC that was applicable here and not Article 25 EC, the Court had to ascertain whether the charge was designed to protect other fruit on the national market, in particular that typically grown in Italy. This was tested on the basis of organoleptic qualities, water content and satisfaction of consumer needs. The Court found here, as it did in Commission v Italy,150 that bananas offer an alternative choice to consumers as fruit. Table fruit typically produced in Italy included apples, pears, peaches, plums, apricots, cherries, oranges and mandarins. These were all differentiated from bananas. Points of difference included the higher water content of pears and other fruit typically grown in Italy, which were seen to possess thirst-quenching properties that bananas do not possess. They were not ‘similar products’. However, while this determined that Article 90(1) EC did not apply, the question of whether Article 90(2) EC, on ‘other products’, was relevant here would have to be tested. Bananas were found to be in at least partial competition with these other fruits due to the interchangeability level of the fruits concerned. While consumers may not choose an apple when they really want a banana, they may choose the banana on occasions if it is competitively priced, and if they are not thirsty. The national taxation system was indirectly protecting domestically grown fruit from competition from other fruits grown elsewhere due to the higher taxation levels imposed on fruits that were not widely produced domestically. The Italian charge was a form of taxation. It was also contrary to Article 90 EC.

149

Case 193/1985, Cooperativa Co-frutta Srl v Amministrazione delle finanze dello Stato [1987] ECR

2085. 150

Case 184/1985, Commission v Italy (banana consumption tax) [1987] ECR 2013.

(C) MacMaolin Ch2

9/2/07

15:15

Page 60

60 Free Movement of Food in the EU 2.3.2 Measures Equivalent to Customs Duties on Intra-Community Food Trade The primary way in which Article 25 EC can impact upon the free movement of food in the EU is in those situations where a Member State imposes a charge for an inspection carried out at its border. Article 25 EC (ex 12) states that: Customs duties on imports and exports and charges having equivalent effect shall be prohibited between Member States. This prohibition shall also apply to customs duties of a fiscal nature.

The Court has made it clear that it is the effect, and not the purpose, of a customs duty, or a charge of equivalent effect to a duty, that is important when assessing whether or not such a levy contravenes Community law.151 Essentially, any additional charge imposed on either the exportation or importation of goods between Member States, no matter how small, or how it is imposed, is prohibited. This includes payment for a service conducted by a Member State, such as, in some circumstances, an inspection to check that food is safe to eat. It is only where a Member State imposes a charge for an inspection that is mandatory under Community law that the Court will accept that it does not contravene Article 25 EC.152 The issue of whether veterinary inspection charges imposed on imports were equivalent to customs duties, even where domestic products and producers were subject to a similar charge, was examined in Bresciani.153 It had already been held that pecuniary charges imposed for reasons of public health examination of products when they cross from one Member State into another were regarded as charges having an effect equivalent to customs duties.154 In Bresciani it was made clear that any pecuniary charge, however small, imposed on goods by reason of the fact that they cross a frontier constitutes an obstacle to the free movement of these goods. Further to this, it was stated that it was of no importance in this regard that the charge imposed was proportionate to the expense of a public health inspection carried out on the goods. An inspection carried out for this purpose was not seen to be a service rendered to the importer which could be lawfully charged to them. The costs of these inspections would have to be met by the Member State. Taxpayers within those Member States were benefiting from the free movement of goods. Costs incurred in the operation of this single market should therefore be borne by the public purse. The fact that domestic production was subject to similar charges for slaughterhouse inspections was not to be taken into account either, unless those charges were applied according to the same criteria and at the same stage of production as those faced by the imported product. It was held that no 151 See, for example, Case 7/1968, Commission v Italy (art exports) [1968] ECR 423; Cases 2/1969 and 3/1969, Sociaal Fonds voor de Diamantarbeiders v SA Ch Brachfeld & Sons [1969] ECR 211; for charges of equivalent effect more specifically, see Case 24/1968, Commission v Italy (statistical levy) [1969] ECR 193. 152 Case 46/1976, Bauhuis v The Netherlands [1977] ECR 5. 153 Case 87/1975, Conceria Daniele Bresciani v Amministrazione Italiana delle Finanze [1976] ECR 129. 154 Case 84/1971, SpA Marimex v Ministero delle Finanze [1972] ECR 89.

(C) MacMaolin Ch2

9/2/07

15:15

Page 61

2.3 Taxes and Duties on the Movement of Food 61 matter what the name or method of applying a charge was, it was to be considered to be a charge having equivalent effect to a customs duty when it was imposed unilaterally on goods imported from another Member State at the point of crossing a frontier, and therefore that its imposition would be contrary to Community law. Charges imposed for inspecting imported poultry meat were examined for compatibility with Article 25 EC in Commission v Belgium.155 Here, Belgian national law prescribed that all poultry meat intended for human consumption must undergo a health check. This check consisted of inspections, both ante- and post-mortem, at Belgian abattoirs, as well as checks at the meat processing plants and during distribution. Imported poultry meat was inspected either at the customs office or at the final destination of the goods, as well as those stages at which domestic meat would also have been examined. Belgium had contended that Directive 1971/118 allowed a Member State to prohibit the marketing of imported poultry meat if it was found to be unfit for human consumption and that this therefore provided that a fee may be charged for any inspection designed to ascertain the fitness of the meat for such consumption.156 This was rejected. The provision of the directive that was relied upon did not oblige the Member State to carry out any inspection, it merely permitted it.157 The directive could not be relied upon to justify the charge, which was of equivalent effect to a customs duty, as the inspection was not necessary in order to apply the terms of the directive. In Bauhuis a cattle dealer sought a refund for fees paid for veterinary and public health inspections carried out by Dutch administrative authorities prior to the export of live animals to other Member States.158 Directive 1964/432 prescribed that such checks take place, provision having to be made for the issuing of a health certificate to accompany the animals to their destination.159 The fact that these inspections were prescribed by the Council through Community law meant that they could not be regarded as unilateral measures which hinder trade; they were rather operations intended to promote the free movement of goods, in particular by rendering ineffective the obstacles to this free movement which might be created by the measures for veterinary and public health inspections adopted pursuant to Article 30 EC. Fees charged to cover the costs of an inspection that is prescribed by a Community provision do not constitute ‘a charge having an effect equivalent to a customs duty on exports’, provided that the charge does not exceed the actual cost of the inspection. This decision was later reaffirmed in Commission v Germany, where charges were passed on for inspections carried out on live 155

Case 314/1982, Commission v Belgium (imported poultry meat) [1984] ECR 1543. Council Directive 1971/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat. [1971] OJ L 55/23; English Special Edition Series I, Chapter 1971(1), p 106. 157 Article 9(1) thereof states: ‘. . . a Member State may prohibit the marketing in its territory of fresh poultrymeat coming from another Member State if at the time of the health inspection carried out in the country of destination it is found that . . . such meat is unfit for human consumption.’ 158 Case 46/1976, Bauhuis v Netherlands [1977] ECR 5. 159 Council Directive 1964/432/EEC of 26 June 1964 on animal health problems affecting intraCommunity trade in bovine animals and swine. [1964] OJ L 121/1977; English Special Edition Series I, Chapter 1963–4, p 164. 156

(C) MacMaolin Ch2

9/2/07

15:15

Page 62

62 Free Movement of Food in the EU animals during transit to ensure that minimum Community standards on animal welfare were being met.160 The Court summarised the exception to Article 25 EC, stating that such fees may not be classified as charges having an effect equivalent to a customs duty if the following conditions are satisfied: (i) they do not exceed the actual cost of the inspections in connection with which they are charged; (ii) the inspections in question are obligatory and uniform for all products concerned in the Community; (iii) they are prescribed by Community law in the general interest of the Community; and (iv) they promote the free movement of goods, in particular by neutralising obstacles which could arise from unilateral measures of inspection adopted in accordance with Article 30 EC. These conditions were deemed to be satisfied by the contested fee in this case. Overall, the Article 25 EC case law clearly demonstrates that Member States may not impose a charge on imported food coming from elsewhere within the Union to cover the costs of inspecting these products, unless that type of inspection is obligatory and has been specifically prescribed by Community law. This is contrary to general Community policy in this area for two reasons. First, the limited exceptions to the rule in Article 25 EC on imposing charges for inspections that the importing Member State deems necessary for human health protection purposes is at odds with the acceptance by the Court in more recent Article 30 EC case law that similar charges may be passed on by the relevant authorities in importing States that require that foodstuffs be subject to a rigorous authorisation procedure prior to their lawful marketing there. Second, in post-BSE Europe, the institutions, and in particular the Commission, have sought to both initiate their own, and support the Member States’, programmes designed to guarantee that only food that is safe is marketed. By obliging Member States to absorb the costs of carrying out inspections on imported food and livestock themselves, even where Community law has recognised that there is a potential danger posed by disease or contamination, as Article 25 EC does, these States are faced with a dilemma. They must either accept this financial burden, or assume that safety inspections carried out in the exporting State meet the required standard. This latter option must be further qualified by an acceptance that the exporting State has been willing to absorb these costs themselves as Article 25 EC also applies to charges of equivalent effect to customs duties on exports. The jurisprudence of the Court on Article 25 EC is very clear. Exceptions to the primary prohibition on this type of behaviour by Member States are limited and well-defined. These rules, and the Court clarifications based upon them, have been long established in Community law. The key cases here all date from the late 1960s to the early 1980s. The rules have become so well established that they are no longer subject to constant challenge, unlike the Articles 28–30 EC jurisprudence which is evolving. One of the key reasons for this is that many of the inspections 160 Case 18/1987, Commission v Germany [1988] ECR 8427. The standards were set down in Article 2(1) of Council Directive 1981/389/EEC of 12 May 1981 establishing measures necessary for the implementation of Directive 1977/489/EEC on the protection of animals during international transport. [1981] OJ L 150/1.

(C) MacMaolin Ch2

9/2/07

15:15

Page 63

2.3 Taxes and Duties on the Movement of Food 63 now undertaken by Member States are covered by Community legislation. These fall outside the scope of the definition of a measure equivalent to a customs duty as clarified by the Court in Commission v Germany. However, for those inspections that the Member State deems necessary that are not covered by any such legislation the dilemma remains. It becomes acute when ‘food crises’ arise, prior to any emergency or other measures being adopted to deal with the situation. It is possible that in such circumstances, the Member States may be able to act on a precautionary basis, but this is likely to extend to conducting the inspections themselves rather than to covering the passing on of costs incurred to the importer as well.161 It is further subject to the requirement that sufficient evidence exists to demonstrate that the risk posed to human or animal health is real and potentially serious. Several key points emerge from an examination of the Article 25 EC case law as it relates to the free movement of food. The decisions of the Court here receive relatively little attention now, primarily because the case law is so well settled at this stage. Article 25 EC contains an absolute prohibition, with exceptions to the general rule a rarity. Clear principles derive from a rule of this nature. Charges of equivalent effect to customs duties may not be passed from the Member State to the importer or exporter unless they are to cover the costs of an inspection specifically prescribed by Community law. However, it is possible that the case law in this area will soon receive more attention, for two connected reasons. The first relates to the new direction that EU food law and policy has taken in the aftermath of the BSE crisis. The emphasis is now firmly on preventing unsafe food from entering the supply chain. This enables Member States to take precautionary action where they suspect, but cannot necessarily verify, that a food source may be unsafe. These precautionary measures include inspections of imported food. The Member State is faced with a dilemma. It can either accept that the safety standards in the suspected Member State are of an acceptable level, thus dispensing with the requirement for any additional inspection.162 Alternatively, the importing Member State can require an additional inspection of the food, paying for this inspection itself. This latter option presents a disincentive to inspect, leaving suspected threats to food safety unexamined. This is entirely at odds with present Community policy designed to ensure that only the safest of food makes it onto the market. It also fails to support Member States and Community institutions in their efforts to protect human health. That is the general reason. The more specific grounds for stating that Article 25 EC jurisprudence may now require re-examination is that the body of recent cases on the compatibility of 161 Inspections carried out by Member States on imported foodstuffs only, and not on domestically produced goods, remain subject to the prohibition set out in Article 28 EC where no reasonable Article 30 EC justification exists. See Case 4/1975, Rewe-Zentralfinanze GmbH v Landwirtschaftskammer [1975] ECR 843. 162 Guidelines for testing the equivalence of sanitary measures do exist at international level. See Codex Alimentarius Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems. Codex Guidelines 53/2003.

(C) MacMaolin Ch2

9/2/07

15:15

Page 64

64 Free Movement of Food in the EU national authorisation procedures with Article 28 EC suggests this. The decisions of the Court here state that these procedures must be accessible and necessary. They do not determine that the charges imposed on an application for authorisation have to be borne by the importing Member State. As with the impermissible charges of equivalent effect to a customs duty, these authorisation costs are not part of a system specifically prescribed by Community law. Presumably, the Member State has the procedure in place because it believes that there may be a risk to human health—just as the Member State that insists on inspecting imported poultry meat believes that such a risk exists. There is no real reason why, where the Member State can demonstrate that the inspection is necessary, or alternatively its lack of a protective element, charges for inspections for health protection purposes should not also be passed on to the importer. The only justification offered for preventing this from happening thus far has been that if the citizens of Member States benefit from the free movement of goods generally, then the costs of inspections should be covered by the importing State’s general revenues that it takes from these same citizens. Nobody benefits from the free movement of what could be dangerous food.163 It is difficult to see how in the light of this new policy direction, coupled with the increased acceptance of the precautionary principle, decisions such as Bresciani and particularly Commission v Belgium, where the introduction of secondary legislation demonstrated that a potential danger had been recognised at Community level, can remain unchallenged when compared to the acceptance of the additional costs being imposed on importers who must comply with a national authorisation procedure before marketing their product, as was the case in both Commission v Denmark and Commission v France. At present, therefore, Article 25 EC does not allow Member States to pass on the costs of inspecting imported food. There is an exception: where this is specifically prescribed by Community law. Where the Community has introduced legislation facilitating the possibility of conducting inspections, recognising that a potential danger to human health exists, Member States may not pass costs in relation to this on to the importer. It is now difficult to reconcile this position with the more general Community position of ensuring that food is as safe as possible, as adopted post-BSE crisis, and culminating in the publication of the White Paper on Food Safety, and ultimately leading to the establishment of the European Food Safety Authority. 2.4 CONCLUSION

The case law of the European Court of Justice makes it clear that a Member State will be in breach of its Treaty obligations where measures that restrict the free movement of food in some way are adopted to protect consumers, to support fair trade, or to promote human health. The only exception to this is where the offending State can adequately demonstrate that it could not have chosen a less 163

Assuming there is no dishonesty involved.

(C) MacMaolin Ch2

9/2/07

15:15

Page 65

2.4 Conclusion 65 restrictive alternative measure to achieve the same aim. Since the decision in Cassis, once a foodstuff is lawfully marketable in one Member State it must be lawfully marketable in all. While this obviously facilitates free movement, the limited way in which the exceptions to this mutual recognition rule have been applied runs counter to other provisions of the EC Treaty, most notably Article 30 EC, but also potentially Article 151 EC on promoting national and regional diversity, Article 152 EC on protecting human health and Article 153 EC on safeguarding consumer interests.164 While the Court has been more ready to accept health protection justifications based upon Article 30 EC in recent years, exceptions to the fundamental principle of free movement for goods continue to be interpreted in an overly restrictive manner. In general, the only measure that Member States may be allowed to adopt to protect consumers or human health is to require that products display more explicit information on their labelling. This is less restrictive of intra-Community trade than a prohibition on the use of a particular food name, for example. However, as has been demonstrated here, this does not present a solution in many circumstances where a Member State seeks to provide protection from deceptive practices or unsafe food. By creating a panacea such as this, the Court has failed to distinguish between the different sets of circumstances that are presented before it. Allowing two bottles of liqueur with roughly the same level of alcohol content to be marketed using the same name may be acceptable where the label brings this to the attention of the consumer, but allowing an alcohol-free version to use the same name is a different matter altogether. In addition to this, requiring that the labelling be altered to indicate a difference that exists between an imported product and one generally known by that name in the host State is also contrary to Article 28 EC in many situations. It is on the basis of the reasoning in these cases that the Commission subsequently decided to cease setting harmonised compositional standards for individual foodstuffs. A limited re-introduction of this programme is now required to address the many deficiencies and inconsistencies that exist within the Article 28 EC case law, as have been identified in this chapter. This is discussed further in Chapters 3 and 7 below.

164 For further discussion see C MacMaoláin, ‘Free Movement of Foodstuffs, Quality Requirements and Consumer Protection: Have the Court and the Commission Both Got It Wrong?’ (2001) 26 European Law Review 413.

(C) MacMaolin Ch2

9/2/07

15:15

Page 66

(D) MacMaolin Ch3

9/2/07

15:16

Page 67

3 Harmonising Food Standards in the EU: Labelling, Naming and Quality Preservation 3.1 INTRODUCTION

S WITH MANY other aspects of the development of Community law, the Courts, through their intervention in the integration process, increased the pace in creating the single market for foodstuffs.1 The Court of Justice’s expansive interpretation of the rule on measures equivalent to quantitative restrictions, and its restrictive interpretation of the exceptions, removed the immediate need for legislative intervention facilitating free movement. However, some harmonising legislation had already been introduced prior to the decision in Cassis.2 A piecemeal and discordant set of standards, primarily directives, had been drafted to set common rules for the production and marketing of food in the Community. This legislation was both vertical (applying to specific foodstuffs only) and horizontal (applying to all foodstuffs) in nature. The vertical legislation consisted primarily of a series of directives setting compositional requirements for some foods, such as chocolate and honey. The horizontal legislation included standardised rules for all foodstuffs, such as those setting out how the weight or volume of a product was first to be determined and then labelled. One thing was very clear from the body of legislation that was devised, if it can be called a body: it would never have the desired effect of creating a single market for foodstuffs. The various pieces of secondary legislation were largely unrelated to each other, dealing with diverse, usually very specific, aspects of the food production process. However, it is here contended that developing a variation on this system in a more co-ordinated manner may now be the best way of resolving the difficulties relating to quality maintenance and consumer protection that have developed post-Cassis, as discussed in Chapter 2 above. What is now required is an amalgamation of the Court-developed principles stemming from its

A

1 See also A Arnull, The European Union and its Court of Justice 2nd edn (Oxford, OUP, 2006); LN Brown and T Kennedy, The Court of Justice of the European Communities 5th edn (London, Sweet & Maxwell, 2000). 2 Case 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649.

(D) MacMaolin Ch3

9/2/07

15:16

Page 68

68 Harmonising Food Standards in the EU Articles 28–30 EC case law with a set of clear, vertical and horizontal, directives and regulations, setting minimum standards for the production and marketing of food throughout the Union. This chapter commences by illustrating how the Community institutions arrived at the conclusion that setting harmonised food standards was no longer necessary in the post-Cassis era. It will be shown that such an approach is overly simplistic and threatens the quality and diversity of foodstuffs available in the EU. The legislation that has been brought into existence in attempts to equalise the national rules of the 25 Member States is then assessed. In particular, Community legislators have introduced harmonising measures that set minimum standards for the protection of consumers by devising some general rules on food labelling. Arising out of this, and following on from inherent problems that can be created for consumers by invoking the mutual recognition principle, rules have also been developed on the use of specific, in particular geographical, food names. This system is primarily designed to preserve the high quality of these foodstuffs. It is here claimed, following a detailed examination of these rules and the related case law, that the system for protecting geographical food names has not had the desired effect. As a consequence, it is demonstrated how further recourse to, and utilisation of, an already existing Community mechanism for protecting the reputation of food products—namely the use of character certificates—should now take place in order to properly preserve the quality and diversity of foodstuffs available in the Member States. The chapter concludes by outlining some of the vertical measures that have been introduced to harmonise standards for specific food products. It is then argued that the increased use of similar legislative initiatives could help to remedy some of the difficulties identified. 3.2 COMPLETING THE INTERNAL MARKET: COMMUNITY LEGISLATION ON FOODSTUFFS

The Commission produced a communication in 1985, as a follow-up to its White Paper on completing the internal market,3 setting out its strategy for the creation of a single market in the foodstuffs sector.4 The White Paper suggested that the recommended strategy for achieving this aim by the completion date of 1992 was to move away from reliance on traditional methods of harmonisation and towards combining the principles of mutual recognition of national regulations and standards based on Articles 28 to 30 EC with a more efficient mechanism for the harmonisation of laws based, in particular, on Articles 94 EC (ex 100) and 95 EC (ex 100a).5 It was stated in the Communication that two significant advances in 3

Commission White Paper on completing the internal market. COM (85) 310. Communication from the Commission to the Council and to the European Parliament on the completion of the internal market: Community legislation on foodstuffs. COM (85) 603. 5 Ex Articles 100 and 100a. The White Paper stated that two communications would be required to clarify how the Community should best proceed on both the harmonisation and mutual recognition issues (ss 71 and 156). The first of these to be introduced was the 1985 Communication on the completion of the internal market in the foodstuffs sector. COM (85) 603 final. The second, on the free 4

(D) MacMaolin Ch3

9/2/07

15:16

Page 69

3.2 Completing the Internal Market 69 Community law could assist in this process. The first was to extend the provisions of Directive 1983/189, which obliges Member States to notify the Commission in advance of draft technical regulations and standards, to the foodstuffs sector.6 The second was to extend the scope of the Council Resolution on a new approach to technical harmonisation and standards, which was designed to simplify and speed up the decision-making process for opening up the internal market, to the foodstuffs sector.7 It was recognised that this latter option would require more careful planning given the nature of the food sector, in particular due to the sensitivity of public opinion in this field, the detailed nature of many national laws and the almost complete lack of standards defining the composition of products. In order to implement this strategy, the Commission would be required to make a clear distinction between those matters that still required legislative action, and those that did not. A new distinction would have to be made between subjects that would require the legislative powers of the Council and those that were within the Commission’s competence. The Communication noted that the existing system of decision-making in the Council led to a series of impasses that were blocking progress in the development of Community food legislation. A clear example of this could be seen in relation to the negotiations on the alteration of the compositional rules for chocolate.8 Unless this changed, disputes on the basis of Article 28 EC would require regular recourse to the Courts. Given the unsatisfactory position that this would create, in particular for an already overburdened Court system and overstretched Commission, it was suggested that many matters that required unanimous Council approval could instead be switched to the simplified and qualified majority Standing Committee on Foodstuffs procedure. Responsibility for the basic rules of Community food law would remain with the Council. This would be appropriate given the Council’s relative success in obtaining agreement on framework horizontal legislative measures when compared to the slim possibility of obtaining agreement on more specific matters, such as the approval of new additives that were considered by the scientific committees to be safe enough to be included on the Community positive lists for such substances. The Commission would be responsible for overseeing the implementation of the legislative measures adopted by the Council. The Standing Committee for Foodstuffs procedure would ensure close co-operation between the Member States and the Commission. In all circumstances, however, where a potential public health problem existed, the Scientific Committee for Food would have to be consulted. Other measures that would have to be taken to remove all obstructions to the advancement of Community food legislation included the following: derogations for movement of foodstuffs within the Community, which was due to be published in 1987, appeared in 1989. [1989] OJ C 271/3. 6 Council Directive 1983/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations. [1983] OJ L 109/8. 7 Council Resolution on the new approach to technical harmonisation and standards. [1985] OJ C 136/1. 8 As discussed in Chapter 1 above.

(D) MacMaolin Ch3

9/2/07

15:16

Page 70

70 Harmonising Food Standards in the EU Member States from Community legislation of general application, such as the framework directive on food labelling, would need to be eliminated. The Communication noted the acceptance of the principle that technical barriers to trade in foodstuffs resulting from mandatory national provisions could be eliminated only by adopting a Community provision of the same nature. The harmonisation programme that was adopted in 1969, and later updated in 1973, was based on that approach. This programme had suggested that there were 50 sectors relating to food which required Community legislation. By 1985, directives had been adopted in only 14 of these sectors, with proposals outstanding in a further six. Those already supported by harmonising legislation included labelling, preservative use, antioxidant use and foods for particular nutritional uses. There were proposals outstanding for sampling and analysis methods, the use of flavourings, the use of extraction solvents, chemically modified starches, frozen foods, and baby foods. Measures were also being prepared to control the use of irradiation techniques and inspection measures. Hence good progress had been made in relation to the introduction of horizontal measures of general application (such as labelling or additive use), but this was not the case for vertical restraints, which related to specific foodstuffs. There were several recipe laws, setting compositional requirements for products such as chocolate, honey and fruit juice, but this list had not been expanded.9 It had in fact remained relatively unaltered since the mid-1970s. This suggested to the Commission that the Member States appeared to be able to agree on the general principles of food legislation, but they found it difficult to reconcile their differences regarding requirements for the composition of individual foodstuffs. It was claimed in the Communication that the legislative approach previously followed was based on the assumption that all specific requirements in national legislation on foodstuffs met an essential public need. The Communication called for a revision to this approach, which should be based on a distinction between matters which by their nature must continue to be the subject of legislation and matters which do not need to be regulated. The principles developed by the Court of Justice in Cassis and its subsequent case law would now enable the Community to define a system of food legislation that contained only provisions that could be justified as being necessary to satisfy essential requirements in the general interest. Measures would have to conform strictly to the principle of proportionality. As a consequence, any future Community legislation on foodstuffs would have to be limited to provisions justified by (i) the need to protect public health; (ii) the need to provide consumers with information and protection in matters other than health; (iii) the need to ensure fair trading; or (iv) the need to provide for the necessary public controls. 9 Under what have become known as the ‘recipe laws’, authorisation to use certain product names was a reward for compositional correctness. These rules assumed special importance within the European Union due to frantic efforts to establish a set of standard harmonised rules throughout the common market. Examples of the recipe laws include Directive 1973/241/EEC, [1973] OJ L 228/23, on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption, and Directive 1974/409/EEC, [1974] OJ L 221/10, on the harmonisation of the laws of the Member States relating to honey. These are examined in more detail later in this chapter.

(D) MacMaolin Ch3

9/2/07

15:16

Page 71

3.2 Completing the Internal Market 71 This serves to illustrate precisely what was developing, and continues to develop, as regards how the Community institutions view the purpose of Community law. Essentially, Article 28 EC could be invoked if any national measure was not strictly necessary, and it would be for the Community Courts to determine necessity. As a general rule, it might be difficult to prove that any legislation not introduced by the Community was ‘necessary’. However, this then raises further questions about the role of the Community in determining which national rules are to be deemed necessary. If the Member State introduces rules to protect human health, for example, these are likely to be found contrary to Article 28 EC if they inhibit the free movement of food in any way. However, if on one of those rare occasions where the Court does find that a mandatory requirement or Article 30 EC exception can be successfully pleaded by the Member State, then the Community institutions should likewise be compelled to introduce similar measures in order to afford the same protection to human health or consumers throughout the Union. The Communication then turned to examine each of the three key exceptions to the prohibition on measures equivalent to quantitative restrictions in turn, assessing whether harmonising legislation would still be required in each case.

3.2.1 Public Health Protection The Communication recognised that the need to protect human health is reflected in the national laws of all the Member States. Consequently, the Council recognised that the objectives being pursued by the various Member States to protect the health of their people are equally valid, even where different techniques are used to achieve them.10 As a result, the national regulations and inspection systems, despite their differences, attempt to achieve the same objectives and should therefore normally be afforded recognition in all Member States. As discussed in detail in Chapter 2, trade in a product lawfully manufactured and marketed in one Member State may only be hindered by the other Member States if doing so is necessary to satisfy mandatory requirements and to serve a purpose in the general interest. However, it was recognised that the application of this principle, despite enabling the Community and the Member States to remove unjustified barriers to trade, did have certain shortcomings that would need to be overcome. The lack of a clear position, necessitating frequent recourse to the Courts to determine, on a case-by-case basis, whether a barrier is unjustified or excessive, creates uncertainty for national administrations and for industry. The Communication was therefore to serve as a guide for public authorities on their obligations and for Community citizens as to their rights. In addition, in some circumstances situations would arise where common standards would have to be introduced to promote industry, 10 Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards. [1985] OJ C 136/1.

(D) MacMaolin Ch3

9/2/07

15:16

Page 72

72 Harmonising Food Standards in the EU to protect consumers or to encourage competitiveness. These would still require the introduction of harmonising Community measures. Official inspection, which is designed to ensure compliance with health protection rules, must, according to the Communication, by its very nature be a matter for legislation. Official control could not itself be contrary to Article 28 EC, it being necessary to ensure that foodstuffs can move freely within the Community. Official control of foodstuffs is thus a necessary part of ensuring their smooth import and export into and out of the inspecting Member State.

3.2.2 Consumer Protection The Communication noted that there were two possible ways to facilitate consumer interests in EU food law. The first was to develop detailed regulations on the composition and manufacture of each foodstuff. This, in other words, would be to expand the use of recipe laws. The second was to work on the basis that, provided that the purchaser was given adequate information regarding the nature and composition of foodstuffs, it would not be necessary to define these elements in law unless necessary for the protection of human health. The Communication made it clear that the Community must commit itself to the second approach, for a number of reasons. These included the fact that it would not be possible, or desirable, to confine in a legislative straitjacket the culinary riches of the Member States; that legislative rigidity concerning product composition prevents the development of new products and is therefore an obstacle to innovation and commercial flexibility; and that the tastes and preferences of consumers should not be a matter for regulation. Key to ensuring that this favoured option was fully supported by an adequate legislative framework, the Communication elaborated on the future of food labelling rules in the Community. The rejection of furthering the use of recipe laws would require a well-developed and clear system of labelling, presentation and advertising. Rules would be devised to protect producers from unfair competition and consumers from misleading practices. Directive 1979/112 would need to be supplemented to achieve this.11 National exceptions left to the discretion of Member States would need to be replaced by uniform rules, in particular in relation to the use of additive specification in the list of ingredients and date marking. Furthermore, additions and exceptions to general rules which are needed for specific foods, but which are not applicable to all foodstuffs, would need to be drawn up at Community level where no detailed vertical directive exists on quality requirements for those specific foods. Other additions identified as being required, 11 Council Directive 1979/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer. [1979] OJ L 33/1. This has now been replaced by Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29.

(D) MacMaolin Ch3

9/2/07

15:16

Page 73

3.2 Completing the Internal Market 73 and which have since been implemented, included the introduction of rules on nutrition labelling.12 The Communication stated that, given the repeated findings of the Court that Member States could not prohibit the sale of a product not conforming with its own domestic compositional rules, though lawfully manufactured and marketed in accordance with its own national requirements, the Community no longer needed to introduce compositional rules in its legislation. It was recognised that this could be criticised as resulting in legal uncertainty. It was not always clear as to whether a Member State may make an exception to mutual recognition in respect of products imported from other Member States. The only essential requirement that could possibly justify the refusal to accept a food lawfully produced in another Member State is the need to protect consumers against misleading practices and producers against unfair competition. It was stated that existing Community labelling provisions, together with those to be drawn up on additive listing and nutrition labelling, would be sufficient to provide adequate information and avoid confusion. This, it was claimed, would eliminate legal uncertainty. The second potential criticism was that a lack of Community compositional rules would lead to a reduction in quality, as the most liberal national rules would now become general practice. The Communication dissented from this view. It stated merely that there was no evidence available to support this, without making any further elaboration. It added that the Commission would be initiating discussions with those responsible for national food legislation to determine whether and how the Community should encourage industry to adopt an active quality approach for foodstuffs. This could then result in the development of a Community system for the mutual recognition of labels or other quality marks and for the relevant checks and certification to be examined. In particular, this would be necessary because in order to ensure the proper functioning of a system of mutual recognition based on Article 28 EC, there must be accompanying administrative co-operation with all interested parties, including the relevant authorities in the Member States, and representatives from agriculture, industry, labour, commerce and the consumer body. While the Community has established a system for certifying products of quality or character, it is demonstrated later in this chapter how this process remains under-used throughout the EU, and is relatively ineffective in achieving its stated aim. 3.2.3 Fair Trading The Communication stated that once a food was not harmful to health, consumers were adequately and correctly informed and not misled, and producers were protected against unfair competition, then fair trading would, in principle, be ensured. 12 Council Directive 1990/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs, [1990] OJ L 276/40 which is discussed in more detail in Chapter 6 below.

(D) MacMaolin Ch3

9/2/07

15:16

Page 74

74 Harmonising Food Standards in the EU

3.3 COMMUNICATION ON THE FREE MOVEMENT OF FOODSTUFFS WITHIN THE COMMUNITY

The Communication on the completion of the internal market in the foodstuffs sector identified that some matters required Council legislative action, while others were a concern for the Commission. The Commission would monitor the application of Article 28 EC in the Member States, and the initiation of judicial proceedings where necessary. Member States would, however, still be entitled to keep domestic rules that contravened Article 28 EC in place, provided that these rules were justifiable as being necessary for the protection of human health or necessary to satisfy mandatory requirements, including consumer protection and fair trading. These areas would also be the only ones that would require Community legislation. All other situations could be dealt with by the mutual recognition principle. As a consequence, and in particular to clarify what would constitute a legitimate derogation from this principle, the Commission issued a communication in 1989 on the free movement of food in the post-Cassis era.13 This Communication opened by emphasising the importance of the foodstuffs sector. It is one of only a few which have a direct bearing on every individual in the Union. It recognised that clarification on the free movement of food would be required imminently as levels of trade were increasing and, consequently, consumers were now confronted by an ever-greater diversity of foodstuffs on the market, some of which they would not necessarily be familiar with. The Communication set out the Commission’s strategy to cope with any difficulties that this might cause. This strategy was to adopt harmonised rules at Community level, applicable to all foodstuffs marketed in the Community, with the principle of mutual recognition of national regulations and standards for matters not requiring the adoption of Community legislative measures. On the issue of legislation, the Communication stated that the Commission was proposing the adoption of harmonised rules at Community level only for matters relating to public health, the protection of consumers, environmental protection and the fairness of commercial transactions. These would, generally speaking, be horizontal measures covering aspects such as additive use, pesticide residues, materials and articles in contact with foodstuffs, certain manufacturing and treatment processes, and the labelling, presentation and advertising of foodstuffs. Official inspection measures would be regularly supplemented and updated. However, Community measures would also be introduced to cover the implementation of other Community policies, such as standards governing composition or the definition of organic production. The Commission would also promote a policy of product quality at Community level. To achieve this, the Commission would provide for a Community framework for prescribing approval procedures and mutual recognition of quality labels, and for claims concerning recognition of quality 13

Communication on the free movement of foodstuffs within the Community. [1989] OJ C 271/3.

(D) MacMaolin Ch3

9/2/07

15:16

Page 75

3.3 Communication on Free Movement of Foodstuffs 75 products, and claims concerning products of characteristic or traditional origin or manufacture. Integral to all this would be improving the accuracy of descriptions of foodstuffs, particularly as regards the standard of claims made in their labelling. The position in 1989 can be summarised thus. It was recognised that where no Community harmonised rules existed, Member States could set their own standards for the production of food, including those on the manufacture, composition, packaging and presentation of foodstuffs. They would, however, be required to allow onto their territory foodstuffs lawfully produced and marketed in other Member States. The importation of these products, in the absence of harmonised rules, could only be restricted where (i) the national measure could be demonstrated to be necessary in order to satisfy mandatory requirements relating to public health protection, the protection of consumers, the fairness of commercial transactions or the protection of the environment; (ii) the measure was proportionate to the objective; and (iii) the measure chosen was the means of achieving that objective which least hindered trade. The Communication recognised that these principles, which arose out of the judgment of the Court of Justice in Cassis, had been further developed in subsequent case law, in particular the decision in Commission v Germany.14 As a result of this latter decision, and the principles arising therefrom, it was deemed that the basis now existed for resolving most of the problems that were likely to arise in relation to the free movement of foodstuffs, in particular those relating to the name under which imported foodstuffs were sold and the use of additives. As regards food names, the importer could now choose either to keep the name under which the product was lawfully marketed in the Member State of manufacture, or to adopt the trade description under which similar products were marketed in the importing Member State. It was also suggested that there was no reason why the product should not bear both trade descriptions simultaneously, provided that this did not confuse the consumer. The only circumstances where this choice could be lawfully restricted would be where the product differed in terms of its composition or manufacture from goods generally known under the same name in the Community, so that the product would not fall under either description. Where the imported product did not possess certain characteristics deemed to be essential in the importing Member State for the use of the specific trade description, it would be the responsibility of the importer to ensure that the labelling of the product provided the consumer with the proper information about the nature and characteristics of the product to enable it to be distinguished from products with which it might be confused. The only circumstances where the marketing of an imported foodstuff could be restricted by the application of national consumer protection measures would be where the labelling of the product itself would be liable to create confusion as to the nature, characteristics or origin of the product and where this could not be avoided by measures that were less of a hindrance to free trade.

14

Case 178/1984, Commission v Germany (bier) [1987] ECR 1227.

(D) MacMaolin Ch3

9/2/07

15:16

Page 76

76 Harmonising Food Standards in the EU What is particularly interesting about the Communication is that it gave clarification on the mutual recognition of the use of additives in foodstuffs. It stated that the importation of a foodstuff containing an additive permitted in the Member State of manufacture, but prohibited in the importing Member State, must be authorised if the additive does not present a danger to human health, taking into account the findings of international scientific research and eating habits in the importing Member State, and if the use of the additive meets a genuine need, in particular of a technological or economic nature. Whilst the relevant case law had alluded to such a position, it had never been quite so explicit as this. To this end, the Member States would have to ensure that they institute an authorisation procedure that would be easily accessible to traders and could be concluded within a reasonable period of time, specifically stated as being no more than 90 days. Under this procedure, it would be for the national authorities in the Member States to demonstrate that the refusal to grant authorisation is justified on grounds relating to the protection of public health. Furthermore, it must be open to traders to challenge an unjustified failure to grant authorisation before national courts.15 The Communication stated that the key aspiration of Community food legislation is to ensure a high level of human health protection and that the consumer is accurately and adequately informed as to the nature, characteristics and, where appropriate, origin of foodstuffs placed on the market. Any aspects of the free movement of foodstuffs not covered by Community legislation would be provided for by the case law of the Court of Justice. It was stated that: The completion of an internal market in this sector, accompanied by an active promotion of product quality, should also ensure consumer access to the great variety of the Community’s agri-food production by offering the producers the advantages and outlets of a large market.

The Communication also set out what the Commission intends to be the key features of the Community food law framework, including: (i) protecting consumers against misleading practices, and consequently ensuring fair trading, by providing a set of horizontal rules that will ensure that they are correctly and precisely informed of the nature and characteristics of products and, in some cases, the provision of vertical legislation as considered necessary for the implementation of other Community policies, for example setting compositional requirements (although only in very limited circumstances), production methods or defining organic foodstuffs; and (ii) following on from its Communication ‘The future of rural society’, the promotion of product quality standards in order to protect agricultural and food products that are known for their high quality level (pasta from durum wheat, cheese types) or which are geographical in nature (protected designations of 15 For further detail on this see, in particular, Case C-344/1990, Commission v France (cheese nitrate) [1992] ECR I-4719, para 9; Case C-24/2000, Commission v France (fortified foods-‘Red Bull’) [2004] ECR I-1277, para 26.

(D) MacMaolin Ch3

9/2/07

15:16

Page 77

3.4 Food Labelling 77 origin (pdo) and protected geographical indications (pgi)), as well as ensuring that modes of production, such as ‘free range’ or ‘traditional’ become or remain the demesne of genuine cases.16 Where no Community rules exist, Articles 28 to 30 EC apply. The most important and influential of those rules that have been developed are the horizontal standards on food labelling. Primarily it is the existence of this legislation, coupled with the decision in Cassis, that has led to, and has justified, the policy of not harmonising food standards throughout the Community—facilitating free movement without common standards. 3.4 FOOD LABELLING

Given that consumers have, particularly since the latter decades of the 20th century, become increasingly concerned about the constituents of their food,17 it is not surprising that the area of EU food law that, in general, leads to the most contention is food labelling. There are several reasons for this. Primarily there appears to be a belief, often a well-founded one, that food producers’ main concern is the maximisation of profit, and that in their efforts to achieve this, undesirable practices will occur. This can include replacing natural colours and flavours with artificial ones, adding ingredients that have undergone certain processes or that have been produced in a particular way, for example ionisation or genetic modification, or making claims about a product’s origin, health benefits or quality level that are untrue or exaggerated. More recently there have also been increasing calls for fat content levels, nutritional values and the presence of potentially harmful substances, such as trans-fats or monosodium glutamate, to be disclosed. Consumer groups seek clearer labelling information.18 Producers want to maximise the area on the packaging that they can use for the advertising of their product. Legislators must try, where possible, to appease both interests. This is a difficult task, complicated by the fact that those drafting legislation are faced with a clear paradox. Overburdening the producer with legislative requirements reduces efficiency and consequently stifles economic progress, but it also reduces the clarity of the labelling information presented to the consumer. Neither party is thus best served by this approach. Indeed, many studies have shown that despite constant calls for more information, doubt has been expressed as to whether

16

Commission Communication on the future of rural society. COM (88) 501. See, for example, MS Brewer and CJ Prestat, ‘Consumer Attitudes toward Food Safety Issues’ (2002) 22 Journal of Food Safety 67; Rodolfo M Nayga, ‘Sociodemographic Influences on Consumer Concern for Food Safety: The Case of Irradiation, Antibiotics, Hormones, and Pesticides’ (1996) 18 Review of Agricultural Economics 467; M Wandel, ‘Understanding Consumer Concern about Foodrelated Health Risks’ (1994) 96 British Food Journal 35. 18 See, for example, A Shine, S O’Reilly and K O’Sullivan, ‘Consumer Use of Nutrition Labels’ (1997) 99 British Food Journal 290. 17

(D) MacMaolin Ch3

9/2/07

15:16

Page 78

78 Harmonising Food Standards in the EU consumers actually read or even comprehend many labelling disclosures.19 Too much information can cause consumers to make even more disorientated decisions than those made when there is less information to hand.20 Food labelling was one of the earliest, and continues to be one of the more comprehensively, covered areas of EU food law. This completeness derives mostly from the clarity of rules rather than any large mass of requirements. Food labelling was the subject of a well-drafted framework directive as early as 1979.21 This legislation was replaced in 2000,22 the new rules being simply a necessary modernisation, consolidation and minor modification of the original.

3.4.1 Framework Food Labelling Legislation Directive 1979/112 was one of the earliest drafted pieces of horizontal Community food legislation, encompassing all food and food products rather than specific foodstuffs, as had been the case with the earlier ‘recipe laws’. It was recognised that the primary consideration for any rules on the labelling of foodstuffs should be the need to inform and protect the consumer.23 As a consequence, a list of specific labelling requirements was established that would have to appear on all foodstuffs intended for sale to the ultimate consumer, with some minor exceptions. It was intended that the directive would establish the framework around which supplementary measures could be adopted to deal with specific, both horizontal and vertical, circumstances.

19 Successive studies have demonstrated that many consumers remain unable and/or unwilling to understand much of the information that is presented to them on food labels. See, for example, E Einsiedel, ‘Consumers and GM Food Labels: Providing Information or Sowing Confusion’ (2000) 3 Journal of Agrobiotechnology Management and Economics 231; L Levy, RE Patterson, AR Kristal and SS Li, ‘How Well do Consumers Understand Percentage Daily Value on Food Labels?’ (1999) 14 American Journal of Health Promotion 126; DJ Reid and SM Hendricks, ‘Consumer Understanding and Use of Fat and Cholesterol Information on Food Labels’ (1994) 85 Canadian Journal of Public Health 334; W Mueller, ‘Who Reads the Label?’ (1991) 28 American Demographics 36. For further data and discussion on European consumers’ interest in, and comprehension of, labelling see ‘European Consumers’ Attitudes on Product Labelling’ published by the European Commission in May 2005, available at http://ec.europa.eu/consumers/topics/product_labelling_en.htm. 20 See, for example, JC Kozup, S Burton and EH Creyer, ‘The Provision of Trans Fat Information and its Interaction with Consumer Knowledge’ (2006) 40 Journal of Consumer Affairs 163; KR France and PF Bone, ‘Policy Makers’ Paradigms and Evidence from Consumer Interpretations of Dietary Supplement Labels’ (2005) 39 Journal of Consumer Affairs 27; and S Burton and JC Andrews, ‘Age, Product Nutrition, and Label Format Effects on Consumer Perceptions and Product Evaluations’ (1996) 30 Journal of Consumer Affairs 68. 21 Council Directive 1979/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer. [1979] OJ L 33/1. 22 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 23 Preamble to Council Directive 1979/112/EEC.

(D) MacMaolin Ch3

9/2/07

15:16

Page 79

3.4 Food Labelling 79 ‘Labelling’ was defined in the directive as being: any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff.24

It was stated that the labelling must not: be such as could mislead the purchaser . . . particularly as to the characteristics of the foodstuff . . . its nature, identity, properties, composition, quantity, durability, origin or provenance, method of manufacture or production.25

The directive set out a series of indications that must, unless specified elsewhere, be compulsorily presented on all foodstuffs. These included: the name under which the product is sold, the list of ingredients, the net quantity of prepackaged foodstuffs, the date of minimum durability, any special storage conditions or conditions of use, and the name or business name and address of the manufacturer or packager or of a seller established within the Community.26 In addition to this, particulars relating to the place of origin must be detailed where failure to give such particulars might mislead the consumer as to the true origin of the foodstuff and instructions for use must be supplied where it would be impossible for the consumer to make appropriate use of the foodstuff in the absence of such information.27 Directive 1979/112 was later replaced by Directive 2000/13.28 This directive strays little from the requirements of the original framework food labelling directive, but it does include some important additions. Provision is made for the inclusion on the label of details relating to quantitative ingredient declarations, the ‘use-by’ date for highly perishable foodstuffs, and the alcoholic strength by volume of beverages containing more than 1.2 per cent by volume of alcohol.29 All compulsory labels must be easily visible, clearly legible and indelible.30 They should not be in any way hidden, obscured or interrupted by any other written or pictorial matter.31 ‘Labelling’ continues to be defined as it was in Directive 1979/112. It was noted by the Court in Smanor that labelling includes any words, particulars and other information relating to a foodstuff that is specifically designed to inform the consumer about the characteristics of the product in question, in particular those relating to its nature, identity, properties, composition, quantity, durability, 24

Article 1(3). Article 2(1). 26 Article 3(1). 27 Ibid. 28 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 29 Article 3(1). 30 Article 13(2). 31 Ibid. 25

(D) MacMaolin Ch3

9/2/07

15:16

Page 80

80 Harmonising Food Standards in the EU origin, and method of manufacture or production.32 Labelling must thus be intended to specifically inform the consumer in some meaningful way, in order to come within the scope of Directive 2000/13. Despite this broad definition, not all marks on food packaging are labelling. In Twee Provinciën, for example, a Dutch national cheese mark consisting of a serial number and a combination of letters indicating, inter alia, the region of production and the cheese type did not fall within this definition, and was thus not labelling for the purposes of the directive. This was primarily due to the fact that it was a serial number containing letters that identified the region of production and was not a clear statement about the origin of the product.33 Its primary function was to assist public authorities in the Netherlands in their verification processes designed to ensure that the cheese was produced in accordance with the relevant rules, not to inform consumers. Member States may not forbid trade in foodstuffs which comply with the rules laid down in the directive by the application of non-harmonised national provisions governing the labelling and presentation of certain foodstuffs or of foodstuffs in general.34 Some derogation from this may be allowed to protect public health, prevent fraud or to protect industrial and commercial property rights, or in relation to indications of provenance, registered designations of origin or the prevention of unfair competition.35

3.4.2 Labelling Language Under the terms of the framework food labelling legislation,36 and the case law of the Court of Justice, food labelling is to appear in a language that is easily understood by the consumer, unless other measures have been taken to ensure that the purchaser is informed. The issue of labelling language first came before the Court in Piageme v Peeters.37 There it was found that the framework labelling legislation precluded national law from requiring the exclusive use of a specific language for the labelling of foodstuffs. The legislation permitted the use of another language easily understood by purchasers, or ensuring that the purchaser was informed by other measures. The applicant, a mineral water producers’ association, brought an action against the respondent, a company established in the Flemish-speaking region of Belgium, claiming that the respondent had contravened the framework food labelling directive by selling mineral water in bottles whose labels were only in French or German. It was claimed that the directive required that labelling should appear in a language that is easily understood by the purchaser rather than 32 Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489, para 30. 33 Case C-285/1992, Criminal Proceedings against Coöperatieve Zuivelindustrie ‘Twee Provinciën’ WA [1993] ECR I-6045. 34 Article 18(1). 35 Article 18(2). 36 Article 16 thereof. 37 Case C-369/1989, Piageme and others v BVBA Peeters [1991] ECR I-2971.

(D) MacMaolin Ch3

9/2/07

15:16

Page 81

3.4 Food Labelling 81 in any specific language. The transposing Belgian legislation stated that the language to be used should be that of the linguistic region where the foodstuff was being offered for sale. While the Court accepted that the language of a region was that which was most likely to be the one that would be ‘easily understood’, such an interpretation of the provisions of the framework food labelling legislation would fail to take account of the true aims of the directive, in particular facilitating the free movement of goods. To require that a specific language be used was determined to be a measure equivalent to a quantitative restriction on imports and consequently contrary to Article 28 EC, as well as to the aims of the directive. In Piageme v Peeters (No 2) it was questioned whether ‘other measures . . . taken to ensure that the purchaser is informed’ was restricted to particulars on the label of a product and, if not so restricted, it could also include the entire context in which a product was offered for sale, provided that the information required by the framework food labelling legislation was given in full, and in a manner that could be easily understood by the consumer.38 The Court noted that the aim of the legislation was to ensure that the consumer was given easy access to the compulsory particulars specified in the directive. It was necessary that these particulars should be available to the consumer both at the time of purchasing and at the time of actual consumption. This was seen to be particularly true in relation to the date of minimum durability and any special storage conditions or conditions of use of the product. The Court noted that the ultimate consumer is not necessarily the purchaser of the foodstuff. It stated that consumer protection could not be adequately ensured by measures other than labelling such as, for example, information supplied at the point of sale or as part of a wide-ranging advertising campaign. All the compulsory particulars specified in the framework food labelling directive must thus appear on the labelling in a language easily understood by purchasers, or by other measures such as designs, symbols or pictograms. It would be for the national court to determine in each individual case whether that which appears on the labelling gives consumers full information as to the compulsory particulars specified in the directive. It is also for the national court to determine in each individual case whether the compulsory particulars given in a language other than the language mainly used in the Member State or region concerned can be easily understood by consumers in that State or region. When determining whether a language used or particulars given are sufficient to inform the consumer, various factors may be relevant, though not necessarily decisive. Examples include the possible similarity of words in different languages, the widespread knowledge amongst the population concerned of more than one language, or the existence of special circumstances, such as a wide-ranging advertising campaign or widespread distribution of the product. Member States should always refrain from laying down requirements more detailed than those already contained in the directive.39

38 39

Case C-85/1994, Piageme and others v Peeters NV [1995] ECR I-2955. Article 17 of Directive 2000/13.

(D) MacMaolin Ch3

9/2/07

15:16

Page 82

82 Harmonising Food Standards in the EU In Goerres, proceedings were brought against the respondent for offering for sale in his shop in Germany various foodstuffs, including orange soda, corn flakes and pasta sauce with olives and capers, that were not labelled in German.40 The foodstuffs were labelled in French, Italian or English. The rules transposing the food labelling directive into German law did clearly state that while German should be used on food labelling, the compulsory particulars could be given in another language, if the provision of information to the consumer was not adversely affected in any way by this. The respondent lodged an objection to the penalty served upon him (a DM2,000 fine), claiming that use of a particular language could not be imposed under the terms of the directive. The decisive factor was the intelligibility of the labelling and that given that the products in question were well known to the public, the use of labelling in a foreign language did not adversely affect the information imparted to the consumer. He further stated that he had placed in his shop, adjacent to the products in question, supplementary signs giving the required information in German. It was noted by the Court that following its decision in Piageme (No 2) that it was for national courts to assess, in the light of all the circumstances in each individual case, the ease with which information supplied in a language other than that of the place of sale could be understood. The Court added that it had to be borne in mind that the required particulars could be satisfactorily indicated other than by words, for example by designs, symbols or pictograms. It thus had to be determined whether placing a supplementary sign in a shop, adjacent to the product in question, containing the prescribed particulars in a language which could be easily understood, was sufficient to ensure that the consumer was informed. The Court decided that it was not. The key aim of the directive—to inform and protect consumers—would not be attained if they did not always have access to the compulsory particulars specified in the directive, not only at the time of purchase but also at the time of consumption. The issue of labelling language was once more the subject of the Court’s deliberations in Geffroy.41 Here, an inspection carried out at the premises of one of the co-respondents revealed that the labelling on certain drinks, namely bottles of cola, cider and ginger ale, was not in French, save for the indications of volume and, in the case of the ginger ale, the alcohol content. It was contested that the cola, the labelling of which was in English, was a well known product that could not be confused with any other by consumers. It was also claimed that the suppliers of the cider and ginger ale had made a mistake by failing to provide the adhesive stickers in French to be attached to the bottles, as they had been requested to do. The rules transposing the framework food labelling directive into French law stated that all the labelling particulars required must be written in French. The respondent claimed that these French provisions were in fact incompatible with the terms of 40

Case C-385/1996, Criminal proceedings against Hermann Josef Goerres [1998] ECR I-4431. Case C-366/1998, Criminal proceedings against Yannick Geffroy and Casino France SNC [2000] ECR I-6579. 41

(D) MacMaolin Ch3

9/2/07

15:16

Page 83

3.4 Food Labelling 83 the directive, in particular in that they required the use of a specific language for the labelling of foodstuffs. Following its earlier case law on the matter, and the perceived aims of the directive, the Court agreed, finding that Article 28 EC and the terms of the directive precluded a national provision from requiring the use of a specific language for the labelling of foodstuffs, without allowing for the possibility of another language easily understood by purchasers to be used or for the purchaser to be informed by other means. Finally on the issue of labelling language, the directive states that Member States are to prohibit the sale of foodstuffs that do not carry labelling in a language that can be easily understood by consumers likely to purchase or consume those foodstuffs.42

3.4.3 Listing Ingredients Under the terms of Directive 2000/13, the ingredients of a food product must be listed in all cases, bar a few exceptions.43 Those foodstuffs that need not include a list of ingredients on the labelling include: fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated; carbonated water, the description of which indicates that it has been carbonated; fermentation vinegars derived exclusively from a single basic product, provided that no other ingredient has been added; cheese, butter and fermented milk and cream, provided that no ingredient has been added other than lactic products, enzymes and microorganism cultures essential to manufacture, or the salt needed for the manufacture of cheese other than fresh cheese and processed cheese; and products comprising a single ingredient where the trade name is identical to the ingredient name, or the trade name enables the nature of the ingredient to be clearly identified.44 ‘Ingredients’ are defined as: any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form. Where an ingredient of the foodstuff is itself the product of several ingredients, the latter shall be regarded as ingredients of the foodstuff in question.45

A compound ingredient may be included in the list of ingredients under its own designation, where this has been laid down by law or established by custom, in terms of its overall weight, provided that this is immediately followed by a list of its ingredients. This list is not required, however, where the compound ingredient constitutes less than 25 per cent of the finished product. This exemption does not extend to additives. Likewise, a list of ingredients is not required for a compound ingredient where this ingredient is a foodstuff for which a list of ingredients is not 42 43 44 45

Article 16(1) of Directive 2000/13. Article 6(1). Article 6(2). Article 6(4)(b).

(D) MacMaolin Ch3

9/2/07

15:16

Page 84

84 Harmonising Food Standards in the EU required under the terms of the directive.46 The following are not regarded as ingredients for the purposes of the legislation: the constituents of an ingredient which have been temporarily separated during the manufacturing process and later reintroduced but not in excess of their original proportions; additives whose presence in a given foodstuff is solely due to the fact that they were contained in one or more ingredients of that foodstuff, provided that they serve no technological function in the finished product or provided that they are used as processing aids; and substances used in the quantities strictly necessary as solvents or media for additives or flavouring.47 Decisions may be taken in individual cases at Community level to ascertain whether the additives used are among those which EU law specifies may be omitted from the list of ingredients.48 Just what qualifies as an exemption from the ingredients list has previously aroused some level of controversy. In Pfanni Werke, for example, the applicant, a manufacturer of dehydrated potato products, was adding diphosphate E450a to the ingredient ‘potato puree flakes’ in order to counteract grey discolouration of the flakes caused by enzymes during the production process.49 Objections had been raised about the fact that this additive was not subsequently included in the list of ingredients. It was claimed that its use affected the colour of the finished product and that it should therefore be regarded as an ingredient under the terms of the framework labelling legislation; it served a technological function in the finished product. The applicant had been informed that if it continued to omit this additive from the list of ingredients, then a formal prohibition order would be made and a fine imposed. The applicant responded by initiating an action against the relevant authorities, claiming that the additive actually served no technological function in the finished product. It was added to the potato pulp to prevent it from changing colour. The preparation of the pulp was only one stage in the manufacturing process of the ingredient ‘potato puree flakes’. After the subsequent dehydration of that pulp the colour of the potato flakes in the finished product could no longer be affected, because the enzymes in the potato cells were neutralised through heating. The claim was that diphosphate E450a should not thus be required to be listed by the applicant. During the course of the proceedings, it was submitted to the Court that any additive which directly or indirectly influences the characteristics of the finished product must be included in the list of ingredients. This is especially so, given that the aim of the framework food labelling directive is to prevent consumers from being misled by the labelling of foodstuffs and to inform them as fully as possible about the product’s composition. This was not accepted by the Court. It held that although the directive was based on the need to inform and protect the consumer by, inter alia, compelling producers to state a list of ingredients on the labelling, that obligation was subject to various derogations, including one relating to the 46 47 48 49

Article 6(8). Article 6(4)(c). Article 6(4)(d). Case C-144/1993, Pfanni Werke Otto Eckart KG v Landeshauptstadt München [1994] ECR I-4605.

(D) MacMaolin Ch3

9/2/07

15:16

Page 85

3.4 Food Labelling 85 technological function of additives in the finished product. Consumers are to be provided with effective information which can be easily understood. In the opinion of the Court this did not mean an exhaustive list of the ingredients used in the manufacturing process. It was accepted that the additive at issue no longer served a technological function in the finished product given that the risk of the potato pulp acquiring a grey discolouration no longer existed after the heating and dehydration process, because the enzymes that could be discoloured had already been neutralised by the heating and dehydration process. The list of ingredients must include all the ingredients of the foodstuff, in descending order of weight, as recorded at the time of their use in the manufacture of the product. It must be preceded by a suitable heading that includes the word ‘ingredients’.50 Where the ingredients include a mixture of fruit or vegetables, or spices or herbs, where none significantly predominates in proportion by weight, those ingredients may be listed in any order, provided that the list of ingredients is accompanied by an expression such as ‘in variable proportion’.51 Some ingredients, belonging to specified categories, may, where they are the constituents of another foodstuff, be designated by the name of the relevant category only.52 Examples include all types of cheese, where the cheese or mixture of cheeses constitutes an ingredient of another foodstuff and provided that the name and presentation of the product does not refer to a specific type of cheese. This may appear in the ingredients listing simply as ‘cheese’. Similarly too, all species of fish, where the fish constitutes an ingredient of another foodstuff and provided that the name and presentation of the product does not refer to a specific species of fish, may be listed simply as ‘fish’. Similarly, all herbs or spices not exceeding two per cent by weight of the foodstuff may be listed as either ‘herbs’ or ‘spices’ respectively.53 Colours, preservatives, flavour enhancers, sweeteners, antioxidants, emulsifiers, thickeners, gelling agents, stabilisers, acidity regulators, anti-caking agents, raising agents, anti-foaming agents, glazing agents, flour treatment agents, firming agents, humectants, bulking agents and propellant gases must all appear in the list of ingredients using the name of the category, followed by the specific name or EC number.54 If an ingredient belongs to more than one of these categories then the category appropriate to the principal function in the circumstances must be indicated.55 Where starch or modified starch is present in a product, its appearance in the ingredients listing must always be complemented by the indication of its specific vegetable origin when that ingredient may contain gluten.56

50

Article 6(5). Article 6(5). 52 Article 6(6). 53 Annex I to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 54 Article 6(6). 55 Ibid. 56 Ibid. 51

(D) MacMaolin Ch3

9/2/07

15:16

Page 86

86 Harmonising Food Standards in the EU Member States may not exceed the requirements set out in the framework labelling legislation in respect of the listing of ingredients. In Commission v Germany, for example, it was questioned whether national rules on this were contrary to free movement principles. These required that béarnaise sauce and hollandaise sauce made with vegetable fats, and certain pastry products containing the additive E160F, should carry a trade description with an additional statement indicating that the substances in question had been used. This was so even where those substances had already been included in the list of ingredients referred to in Article 6 of the directive.57 It had been claimed that the national measures were necessary for the protection of consumers. It was contended that consumers often buy foodstuffs without undertaking a scrupulous examination of the product, their choice instead being determined by ‘reference criteria’ such as the trade description and the additional information accompanying it. Consequently it was claimed that, in the case of the sauces at issue, were there no requirement to display the statement in dispute, the consumer could be led to buy those products in the belief that they had in fact been produced according to the traditional German recipe, with eggs and butter rather than vegetable fat. The same, it was claimed, held true of the incorporation of the additive E160F in biscuits and pastry products. The presence of E160F creates an intense yellow colouring, potentially misleading the consumer into believing that a large amount of egg yolk has been used in production. The additional labelling requirements were, however, here found to be unjustified on the grounds of consumer protection. It was held that in certain cases prescribed additional statements may be allowed, but it was the opinion of the Court in this instance that consumers whose purchasing decisions depend on the composition of the product will first read the list of ingredients. It was accepted that on some occasions consumers may be misled, but that this risk was minimal and insufficient to justify the hindrance to the free movement of goods that the national rules at issue created. It was also contended that the following fair trading issue should be examined. The use of ingredients such as vegetable fats, which are less expensive than eggs or butter, enabled the manufacturer of imported products to enjoy a position of considerable competitive advantage. Given that consumers do not sufficiently distinguish between the various methods of manufacture when making purchasing decisions, that advantage was claimed by the German Government to be unacceptable. The Court did not agree. Citing Keck and Mithouard, the Court noted that compositional requirements could not be used to impede free movement, even where the rules are applied without distinction.58 The fair trading argument was rejected on the same grounds as the consumer protection argument. Conscientious consumers would read the list of ingredients and thus be informed of any difference in product quality. 57

Case C-51/1994, Commission v Germany (sauces and pastries) [1995] ECR I-3599. Joined Cases C-267/1991 and C-268/1991, Criminal proceedings against Bernard Keck and Daniel Mithouard [1991] ECR I-6097. 58

(D) MacMaolin Ch3

9/2/07

15:16

Page 87

3.4 Food Labelling 87 Quantitative Ingredient Declarations It is in relation to quantitative ingredient declarations that the 2000 directive departs most from the 1979 framework labelling directive where the listing of ingredients is concerned. The directive states that: The quantity of an ingredient or category of ingredients used in the manufacture or preparation of a foodstuff shall be stated . . . where the ingredient or category of ingredients concerned appears in the name under which the foodstuff is sold or is usually associated with that name by the consumer [or] is emphasised on the labelling in words, pictures or graphics [or] is essential to characterise a foodstuff and to distinguish it from products with which it might be confused because of its name or appearance . . .59

The quantity indicated should be expressed as a percentage, and should correspond to the quantity of the ingredient(s) at the time of use,60 and should appear either in or immediately next to the name under which the foodstuff is sold or in the list of ingredients.61 This is a significant alteration to the original framework food labelling directive. It provides consumers with a transparent mechanism for establishing the quantity of a particular ingredient present in a product. Say, for example, two cartons of cranberry juice sit beside each other on the shelf in a supermarket. One sells for €1.30 per litre; the other for €1.50 per litre. Both are called ‘Cranberry juice drink’. Both display a picture of fresh cranberries on the label. Following the introduction of the requirement that the quantity of cranberries must now be stated, and given that the actual name of the product incorporates the word ‘cranberry’ which is emphasised by a picture on the label, the consumer can now readily identify the actual cranberry content by examining the list of ingredients. It transpires that the €1.30 per litre product contains 15 per cent cranberries; the €1.50 per litre product contains 20 per cent cranberries. The purchaser can now make a fully informed decision as to which product to purchase by weighing up the difference in price against the difference in actual cranberry content.

3.4.4 Net Quantity The net quantity of prepackaged foodstuffs must be indicated on the labelling of products coming within the scope of Directive 2000/13, in units of volume in the case of liquids, and in units of mass in the case of other products, using the litre, centilitre, millilitre, kilogram, or gram as appropriate.62 Similarly, all other foodstuffs sold anywhere in the EU must also be weighed or measured according to the 59 60 61 62

Article 7. Article 7(4). Article 7(5). Article 8(1).

(D) MacMaolin Ch3

9/2/07

15:16

Page 88

88 Harmonising Food Standards in the EU metric system.63 This requirement has caused difficulties in some Member States, in particular in the United Kingdom, where the so-called ‘metric martyrs’ hit the headlines following their refusal to depart from the imperial measurement system.64 Under the terms of the directive, where a prepackaged foodstuff consists of two or more individual prepackaged items containing the same quantity of the same product, the net quantity must be indicated by specifying the net quantity contained in each individual package and the total number of packages. This indication is not, however, compulsory where the total number of individual packages can be clearly seen and easily counted from the outside and where at least one indication of the net quantity contained in each individual package can be clearly seen from the outside.65 Where a foodstuff is normally sold by number, Member States need not require indication of the net quantity, provided that the number of items can clearly be seen and easily counted from the outside or, if not, is clearly indicated on the labelling.66 Where a solid foodstuff is sold in a liquid medium, such as water, brine, vinegar or fruit or vegetable juice, the drained net weight of the foodstuff must be indicated on the labelling.67 No indication of net quantity is required for the marketing of foodstuffs which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser, or where the net quantity is less than 5 g or 5 ml.68 This provision does not apply to herbs or spices.69 Council Directive 1976/211 sets out supplementary requirements on the statement of the weight or volume on the labels of prepackaged food.70 A product is deemed to be prepackaged when:

63 Council Directive 1980/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 1971/354/EEC. [1980] OJ L 39/40. Amended by Council Directive 1989/617/EEC of 27 November 1989 amending Directive 1980/181/EEC on the approximation of the laws of the Member States relating to units of measurement, [1989] OJ L 357/28 and Directive 1999/103/EC of the European Parliament and of the Council of 24 January 2000 amending Council Directive 1980/181/EEC on the approximation of the laws of the Member States relating to units of measurement, [2000] OJ L 34/17. 64 Thoburn v Sunderland City Council; Hunt v London Borough of Hackney; Harman and Dove v Cornwall County Council; Collins v London Borough of Sutton [2002] EWHC 195; [2003] QB 151. For further discussion see S Boyron, ‘In the Name of European Law: The Metric Martyrs Case’ (2002) 27 European Law Review 771. Interestingly, an exemption granted to the UK and Ireland to continue using pints as the unit of measurement for alcoholic drinks in pubs has led to difficulties for the operators of continental themed bars, who wish to use the metric system to serve their drinks in 500 ml glasses. 65 Article 8(2)(c). 66 Article 8(3). 67 Article 8(4). 68 Article 8(5). 69 Ibid. 70 Council Directive 1976/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products. [1976] OJ L 46/1.

(D) MacMaolin Ch3

9/2/07

15:16

Page 89

3.4 Food Labelling 89 it is placed in a package of whatever nature without the purchaser being present and the quantity of the product contained in the package has a predetermined value and cannot be altered without the package either being opened or undergoing a perceptible modification.71

Once a prepackaged product complies with the terms of the directive it may place the ‘e’ symbol on the packaging to indicate this compliance.72 This symbol must be placed in the same field of vision as the indication of the weight or volume of the product.73 Producers are entitled to affix the ‘e’ symbol to their products without having been specifically authorised to do so by the national authorities, provided that the checking procedures employed have been recognised by the national weights and measures authorities.74

3.4.5 Date of Minimum Durability The date of minimum durability of a foodstuff is ‘the date until which the foodstuff retains its specific properties when properly stored’.75 The date stated must be preceded by the words ‘best before’ when the date includes an indication of the day and ‘best before end’ in other cases,76 accompanied by either the date itself or a reference to where the date is given on the labelling.77 If necessary, the particulars given should be followed by a description of the storage conditions which must be observed if the product is to remain safely edible for the specified period.78 The date must consist of the day, month and year, in uncoded chronological form. However, in the case of foodstuffs which will not keep for more than three months an indication of the day and the month will suffice; for those foodstuffs which will keep for more than three months but not more that 18 months an indication of the month and the year will suffice; and for those foodstuffs which will keep for more than 18 months an indication of the year will suffice.79 Subject to other Community provisions, an indication of the durability date is not required for: fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated; wines, liqueur wines, sparkling wines, aromatised wines and similar products obtained from fruits other than grapes; 71

Article 2(2). Article 3(1). 73 Annex I to Council Directive 1976/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products. [1976] OJ L 46/1. 74 Case 96/1984, Vereniging Slachtpluimvee-Export eV v Rewe-Zentral-Aktiengesellschaft [1985] ECR 1157. 75 Article 9(1) of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 76 Article 9(2). 77 Article 9(3). 78 Ibid. 79 Article 9(4). 72

(D) MacMaolin Ch3

9/2/07

15:16

Page 90

90 Harmonising Food Standards in the EU beverages containing 10 per cent or more alcohol by volume; soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers of more than five litres, intended for supply to mass caterers; bakers’ or pastry cooks’ wares which, given the nature of their content, are normally consumed within 24 hours of their manufacture; vinegar; cooking salt; solid sugar; confectionery products consisting almost solely of flavoured and/or coloured sugars; chewing gum and similar chewing products; and individual portions of ice-cream.80 Foodstuffs that are highly perishable, and are therefore likely to constitute an immediate danger to human health after a short period of time, must, instead of the date of minimum durability, display the ‘use by’ date.81 Again, the date is to be preceded by the words ‘use by’, accompanied by either the date itself or a reference to where the date is stated on the label.82 These particulars must again be followed by a description of the storage conditions that need to be observed to keep the product in prime condition.83 The date stated must consist of the day, the month, and as we have seen in the circumstances outlined previously, the year, in that order and in uncoded form in all cases.84 Any instructions that are given on the labelling of a foodstuff should always be stated in such a way that best enables the consumer to use the foodstuff appropriately.85 3.5 FOOD NAMES

The original framework food labelling directive stated: The name under which a foodstuff is sold shall be the name laid down by whatever laws, regulations or administrative provisions apply to the foodstuff in question or, in the absence of any such name, the name customary in the Member State where the product is sold to the ultimate consumer, or a description of the foodstuff and, if necessary, of its use, that is sufficiently precise to inform the purchaser of its true nature and to enable it to be distinguished from products with which it could be confused.86

Thus, for a foodstuff to be named legitimately under the terms of the directive it had to be a legal name, a customary name or a descriptive name. These categories of food name remain under Directive 2000/13. It is this aspect of the food label that has generated, and that continues to generate, the most debate in the years since the inception of the directive. As discussed in Chapter 2, much of the Article 28 EC case law, for example, is concerned with food naming. In a departure from the 1979 directive, the sales name under which the product is lawfully manufactured and marketed in the Member State of production is allowed, in addition to legal, customary and descriptive names. However, where 80 81 82 83 84 85 86

Article 9(5). Article 10(1). Article 10(2). Ibid. Article 10(3). Article 11(1). Article 5(1).

(D) MacMaolin Ch3

9/2/07

15:16

Page 91

3.5 Food Names 91 this could create confusion amongst consumers in the Member State of marketing, the sales name must be accompanied by other descriptive information which is to appear in proximity to the sales name.87 In some circumstances the name used in the Member State of production may not be used in the Member State of marketing where this could cause confusion amongst consumers.88 It must be noted, however, that no trade mark, brand name or fancy name may be substituted for the name under which the product is usually sold.89 The name under which the product is sold must include particulars relating to the physical condition of the foodstuff or the specific treatment that it has undergone, for example powdered, freeze-dried, deep-frozen, concentrated or smoked, where the omission of these particulars could lead to confusion.90 If ionising radiation has been used, this must be stated.91 The various types of food name that can be used in accordance with Community law have been further clarified by the Court. In Canadane, for example, the Advocate General in his Opinion categorised the various types of food name used in the Community.92 He stated that ‘Community names’ are those which are regulated by Community secondary law and define the characteristics and method of production of the product for the entire Community. These ‘eurofoods’, as he called them, such as honey and chocolate, can be marketed without restriction in all Member States and do not give rise to problems in relation to intra-Community trade. Second, ‘generic names’ are common names used to designate agricultural or food products. They form part of the general cultural and gastronomic stock and may, in principle, be used by any producer. It was noted that the Court’s case law had not at that stage defined ‘generic name’, but that examples of food names that had been found to be generic included yoghurt,93 pasta,94 beer95 and edam cheese.96 The Advocate General also noted how, in many cases, Member States 87

Article 5(1)(b). Article 5(1)(c). 89 Article 5(2) of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109. 90 Article 5(3). 91 Ibid. Also, Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation. [1999] OJ L 6/16. 92 Opinion of Advocate General Ruiz-Jarabo Colomer in Case C-317/1995, Canadane Cheese Trading AMBA and Adelfi G Kouri Anonymos Emoriki Kai Viomichaniki Etaireia v Hellenic Republic [1997] ECR I-4681. The case never proceeded to full Court determination due to subsequent withdrawal. 93 Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489. 94 Case 407/1985, Glocken and another v USL Centro Sud and another [1988] ECR 4233; Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285. 95 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. 96 Case 286/1986, Ministère Public v Gérard Deserbais [1988] ECR 4907. Criteria that can be applied to determine whether or not a food name is generic are now set out in Article 3(1) of Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [2006] OJ L 93/12. 88

(D) MacMaolin Ch3

9/2/07

15:16

Page 92

92 Harmonising Food Standards in the EU adopted national measures requiring certain conditions of production for the use of a generic name. If those requirements were similar in the Member States, imported products may use the generic name in the importing State with no resultant obstacles to intra-Community trade. However, the production conditions normally differ from one State to another, consequently creating a free movement problem. When such a difficulty had come before the Court in the past, the importing State was deemed to be acting contrary to Article 28 EC. Any national measure reserving the use of a generic name to products manufactured in compliance with the laws of one Member State, preventing similar products manufactured in compliance with the laws of another Member State from using the same generic name, was incompatible with free movement rules. Any national measure restricting the use of a generic name to a national variety to the detriment of varieties imported from other Member States where they are lawfully produced and marketed was incompatible with the fundamental principle of the free movement of goods.97 The case law of the Court showed that there were possible justifications to restrictions on such imports, in particular the protection of consumers and fair trading, and, to a lesser extent, the protection of public health. It was noted, however, that the Court considers that the importing State can adequately protect its consumers and ensure fair trading by requiring that the labelling of the imported product show all its characteristics, this labelling requirement being a less restrictive alternative that takes more account of the principle of proportionality than a prohibition on imports or the obligation to market the product under a invented name. It had already been determined that bier98 and pasta,99 produced in Member States other than Germany and Italy respectively, were sufficiently similar, despite differences in composition, for adequate labelling to avoid the risk of confusion amongst consumers and to permit them to be sold under the generic names ‘bier’ and ‘pasta’. However, in Deserbais,100 and to a greater extent in Smanor,101 the Court envisaged as an exception to the general rule of mutual recognition of generic sales descriptions subject to adequate labelling, the possibility that the State of destination might prevent the sale in its territory of a product imported from another Member State under a generic name if its characteristics were substantially different from those of national products marketed under the same name.102 Third, the Advocate General went on to define what he termed ‘geographical’ names. He noted that many food names derive from the location in which they are traditionally produced. The Advocate General stated that geographical names were those ‘used to designate food products which allude to their origin from a 97 Case 193/1980, Commission v Italy (vinegar) [1981] ECR 3019; Case 182/1984, Criminal proceedings against Miro BV [1985] ECR 3731. 98 Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. 99 Case 407/1985, Glocken and another v USL Centro Sud and another [1988] ECR 4233; Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285. 100 Case 286/1986, Ministère public v Gérard Deserbais [1988] ECR 4907. 101 Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489. 102 As discussed in Chapter 2 above.

(D) MacMaolin Ch3

9/2/07

15:16

Page 93

3.5 Food Names 93 particular geographical area’. He found that these names had the following characteristics: they guarantee the geographical origin of the product and indicate that the product possesses certain characteristics arising from that geographical origin; they are proof of the quality of the product; they impart a good reputation to products amongst consumers; and the legal protection of geographical names safeguards producers’ interests against unfair competition and consumers against information that may mislead them. It was noted how sales descriptions that contain place-names cannot always be considered to be geographical in nature. A name embodying a place-name may also be generic, or it may have become so over the course of time, and thus can no longer be considered as being geographical and therefore may not enjoy the legal protection afforded to such names under Community law, either as a protected geographical indication or as a protected designation of origin. The definition of ‘designation of origin’ originally set down in Regulation 2081/1992 was seen to be very similar to that laid down by the case law of the Court, but the new type of name created by this legislation, the ‘geographical indication’, did not appear in the case law.103

3.5.1 Recipe Laws The earliest European Community food laws tended to be vertical in nature, dealing with specific foodstuffs only. In general, these ‘recipe laws’ limited the use of the legal name to those foodstuffs that possessed certain prescribed characteristics, sometimes in set quantities. Directives were introduced setting out a series of requirements for the production and marketing of chocolate and cocoa,104 coffee and chicory,105 fruit juices,106 honey,107 and jams, jellies and marmalades and chestnut purée.108 Most of these original directives have since, primarily due to a multitude of amendments, been simplified and replaced.

103 Council Regulation (EEC) No 2081/1992 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [1992] OJ L 208/1. This has now been replaced by Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [2006] OJ L 93/12. 104 Council Directive 1973/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption. [1973] OJ L 228/23. 105 Council Directive 1977/436/EEC of 27 June 1977 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts. [1977] OJ L 172/20. 106 Council Directive 1975/726/EEC of 17 November 1975 on the approximation of the laws of the Member States concerning fruit juices and certain similar products. [1975] OJ L 311/40. 107 Council Directive 1974/409/EEC of 22 July 1974 on the harmonisation of the laws of the Member States relating to honey. [1974] OJ L 221/10. 108 Council Directive 1979/693/EEC of 24 July 1979 on the approximation of the laws of the Member States relating to fruit jams, jellies and marmalades and chestnut purée. [1979] OJ L 205/5.

(D) MacMaolin Ch3

9/2/07

15:16

Page 94

94 Harmonising Food Standards in the EU Chocolate and Cocoa The original directive setting out the compositional requirements for use of the variety of legal names associated with chocolate was finally replaced after much expense and debate in 2000.109 ‘Chocolate’ was defined in Annex I to the 1973 directive as: the product obtained from cocoa nib, cocoa mass, cocoa powder or fat-reduced cocoa powder and sucrose with or without added cocoa butter, having . . . a minimum total dry cocoa solids content of 35%—at least 14% of dry non-fat cocoa solids and 18% of cocoa butter.

It is similarly, if slightly more simply, defined in the 2000 directive.110 The 1973 directive also set out the compositional requirements for the legitimate use of the legal names ‘plain chocolate’, ‘milk chocolate’, and ‘milk chocolate with high milk content’.111 While chocolate had to contain a minimum of 35 per cent cocoa, milk chocolate with high milk content was only required to contain 20 per cent cocoa. As noted in Chapter 1, this led to a 30 year debate over what should be marketable as chocolate in the EU given the differences in cocoa content and the presence of vegetable fats in place of cocoa butter. In an opinion delivered by the Economic and Social Committee on the simplification of the vertical directives on food arising out of the Edinburgh Summit in 1992, it was noted that of all the proposed Council reforms in relation to the series of directives under scrutiny, the most controversial was that dealing with the issue of vegetable fat in chocolate.112 The resolution of the milk chocolate problem was deemed to be of major significance given that milk chocolate had come to account for up to 85 to 90 per cent of all chocolate sales in the Community.113 The Economic and Social Committee noted that the extension of ingredient labelling to chocolate could assist in dealing with the present problem. If non-cocoa butter vegetable fats had been used in the production of the chocolate, this would feature in any ingredients listing. A further separate declaration about this use was thus deemed to be unnecessary in achieving the aim pursued. The separate declaration does now form part of the amended legislation. 109 Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption. [2000] OJ L 197/19. 110 Annex I to Directive 2000/36/EC. 111 Annex I to Directive 1973/241/EEC. 112 Opinion of the Economic and Social Committee on the simplification of the vertical directives on food: Proposal for a European Parliament and Council directive relation to cocoa and chocolate products intended for human consumption, Proposal for a Council directive relating to certain sugars intended for human consumption, Proposal for a Council directive relating to honey, Proposal for a Council directive relating to fruit juices and certain similar products intended for human consumption, Proposal for a Council directive relating to certain partly or wholly dehydrated preserved milk for human consumption, Proposal for a European and Council directive relating to coffee extracts and chicory extracts, Proposal for a Council directive relating to fruit jams, jellies and marmalades and chestnut purée intended for human consumption. [1997] OJ C 56/20. 113 Opinion of the Economic and Social Committee on the simplification of the vertical directives on food. [1997] OJ C 56/20.

(D) MacMaolin Ch3

9/2/07

15:16

Page 95

3.5 Food Names 95 There is also a health issue attached to the use of vegetable fats in chocolate. It is not solely a quality matter. Some of the vegetable fat varieties permitted for use under the terms of the directive, such as palm oil, are primarily used in the production of soap and candles and their consumption by humans is not advised.114 The 1973 directive had clearly stated that its terms did not affect any provision of the national laws of the Member States that prohibited the addition of vegetable fats other than cocoa butter to chocolate.115 As a consequence, eight Member States had prohibited the addition of vegetable fats other than cocoa butter to chocolate, in the light of their concerns over the effects that such an addition may have on both quality and safety.116 When questioned about the validity of the scientific evidence upon which the new rules set out in the 2000 directive were based, rules that finally and absolutely removed this freedom to prohibit, the Commission stated that the primary responsibility for food safety had to remain with the producers. The role of the competent authorities in the Member States was effectively limited to vetting the extent to which manufacturers comply with their responsibilities through the operation of national monitoring and inspection systems. It is worth noting that the Commission itself has not always been entirely confident about the accuracy with which levels of vegetable fats in chocolate can be detected. In the late 1990s, analysis methods dated from the early 1980s and where five per cent vegetable fats had been used in chocolate production, these methods gave results ranging from three to seven per cent. The degree of accuracy could also be affected by the type of vegetable fat used and by other ingredients that had been added. The use of certain types of vegetable fats, it was noted, resulted in greater or lesser accuracy depending on the type of fat used, and analysis was rendered more difficult where the chocolate had been mixed with other ingredients, for example hazelnuts, which already contain fats. The difficulties that arose in the efforts to find a suitable compromise on the chocolate labelling question illustrate one very good reason why the Community institutions have proved willing to accept the Commission’s position that following the decision of the Court of Justice in Cassis, harmonising vertical food standards are no longer necessary or desirable.117 Some generic foodstuffs, like chocolate, are produced in substantially different ways in different Member States. Harmonising rules present a difficulty here. If no legislation is introduced to standardise what may be lawfully marketable in all Member States then the mutual recognition principle applies—the single minimum standard from amongst those of all Member States must now be the maximum standard allowable for all. If, however, harmonising legislation is introduced, then the standard to be set 114 Those vegetable fats which may be added to chocolate include illipe, palm-oil, sal, shea, kokum gurgi and mango kernel. In addition to this coconut oil may be added to chocolate used for the manufacture of ice cream and similar frozen products. Annex II to Directive 2000/36/EC. 115 Article 14(2). 116 Under the terms of Council Directive 1988/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients, hexane may be used in the production of cocoa butter. [1988] OJ L 157/28. 117 Communication on the free movement of foodstuffs within the Community. [1989] OJ C 271/3.

(D) MacMaolin Ch3

9/2/07

15:16

Page 96

96 Harmonising Food Standards in the EU becomes the subject of debate, with each Member State seeking to have its rules used as a model for the new Community-wide standard for all. For a contentious foodstuff, such as chocolate, this can lead to a 30 year impasse, with Member States taking their own action on the matter in the interim. This consequently frustrates the free movement of this product. At present, Community compositional standards, or ‘recipe laws’, exist for only a handful of food products. There is no obvious reason why rules have been set for chocolate, coffee, honey, fruit juice and jams, other than the fact that secondary legislation had been introduced for these products prior to the delivery of the judgment in Cassis. The decision was taken to cease the legislative harmonisation programme soon after this. Coffee and Chicory As part of the continuing process simplifying Community rules relating to the production and composition of certain specific foodstuffs, arising out of the Edinburgh Summit of the Council in 1992, a new directive was introduced in 1999 setting out the requirements for the production and marketing of coffee and chicory extracts.118 This new directive replaced the original 1977 coffee legislation.119 ‘Instant coffee’ is defined in the directive as being: the concentrated product obtained by extraction from roasted coffee beans using only water as the medium of extraction and excluding any process of hydrolysis involving the addition of an acid or a base. Apart from those insoluble substances which it is technically impossible to remove, and insoluble oils derived from coffee, coffee extract must contain only the soluble and aromatic constituents of coffee.120

The framework directive on food labelling is to apply to those products coming within the scope of the coffee legislation.121 The labelling must include the term ‘decaffeinated’ where the caffeine content does not exceed 0.3 per cent by weight of the coffee-based dry matter.122 This information must be displayed within the same field of vision as the sales description.123 Those extraction solvents which may be used in the decaffeination of coffee, and for which conditions of use are specified, are set out in a 1988 directive.124 They include methyl acetate (also used in paint removers), ethylmethylketone (which, when mixed with hexane—a 118 Directive 1999/4/EC of the European Parliament and of the Council of 22 February 1999 relating to coffee extracts and chicory extracts. [1999] OJ L 66/26. 119 Council Directive 1977/436/EEC of 27 June 1977 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts. [1977] OJ L 172/20. 120 Annex to Directive 1999/4/EC of the European Parliament and of the Council of 22 February 1999 relating to coffee extracts and chicory extracts. [1999] OJ L 66/26. 121 Article 2(a). 122 Article 2(b). 123 Ibid. 124 Council Directive 1988/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients. [1988] OJ L 157/28.

(D) MacMaolin Ch3

9/2/07

15:16

Page 97

3.5 Food Names 97 petroleum product used in the production of chocolate—may induce neurotic effects) and dichloromethane (also used in pesticide products and a recognised carcinogen).125 The original legislation included a requirement that ‘[o]nly raw materials which are sound, genuine and of merchantable quality may be used in the manufacture of [coffee]’.126 There is no similar provision in the 1999 directive. Fruit Juices Having already been replaced in 1993,127 the original legislation on fruit juices128 was again subject to further simplification and consolidation in 2001.129 On this occasion there was no parliamentary involvement in the legislative process. The new legislation was designed to codify and clarify further the original and subsequent related legislative provisions, a task that had already commenced with the introduction of the 1993 directive.130 In particular, this new legislation was to account for two things. First, the introduction of the new quantitative ingredient declaration legislation,131 codified in the framework labelling legislation,132 should be used to compel the producer to clearly indicate when a product is a mixture of fruit juice and fruit juice from concentrate. The list of ingredients must bear the names of both the fruit juices and the fruit juices from concentrate used.133 Where a product is a mixture of fruit juice and concentrate the labelling must sate that it is ‘made with concentrate(s)’ or ‘partially made with concentrate(s)’ as appropriate.134 Second, account should be taken of the nutrition labelling legislation135 as the addition of vitamins to products coming within the

125 Annex to Council Directive 1988/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients. [1988] OJ L 157/28. Council Directive 1992/115/EEC of 17 December 1992 amending for the first time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients, [1992] OJ L 409/31, now prohibits the combined use of hexane and ethylmethylketone. 126 Article 3(1). 127 Council Directive 1993/77/EEC of 21 September 1993 relating to fruit juices and certain similar products. [1993] OJ L 244/23. 128 Council Directive 1975/726/EEC of 17 November 1975 on the approximation of the laws of the Member States concerning fruit juices and certain similar products. [1975] OJ L 311/40. 129 Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption. [2002] OJ L 10/58. 130 Preamble 5 to Directive 2001/112/EC. 131 Directive 1997/4/EC of the European Parliament and of the Council of 27 January 1997 amending Directive 1979/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [1997] OJ L 43/21. 132 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 133 Preamble 7 to Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption. [2002] OJ L 10/58. 134 Article 3(6). 135 Council Directive 1990/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs. [1990] OJ L 276/40.

(D) MacMaolin Ch3

9/2/07

15:16

Page 98

98 Harmonising Food Standards in the EU scope of the directive is permitted in some Member States.136 For fruit nectars, which are ‘[t]he . . . product obtained by adding water and sugars to [fruit juice, concentrated or otherwise]’,137 the labelling must indicate the minimum content of fruit juice, fruit purée or any mixture of those ingredients by the declaration ‘fruit content: . . . % minimum’138 located in the same field of vision as the product name. ‘Fruit juice’ is defined in the legislation as being ‘[t]he . . . product obtained from fruit which is sound and ripe, fresh or preserved by chilling . . . having the characteristic colour, flavour and taste typical of the juice of the fruit from which it comes’.139 The fruit juice directive does authorise Member States to permit the addition of vitamins and minerals to fruit juice.140 Where a juice is made from only one kind of fruit then the name of the single fruit used is to be substituted in the product name for the word ‘fruit’.141 Thus a ‘fruit juice’ as defined in the directive that contains no fruit other than oranges is to be called ‘orange juice’. For products manufactured from two or more fruits, except in some circumstances where lemon juice has been used, the product name must be supplemented by a list of the fruits used, in descending order of the volume of fruit juices or purées included.142 Where three or more fruits have been used, the indication of the fruit types may be replaced by the words ‘several fruits’ or a similar wording, or by a statement of the number of fruits used.143 Where the juice has been sweetened by the addition of sugars, the sales name must include the word ‘sweetened’ or ‘with added sugar’, followed by an indication of the maximum quantity of sugar added.144 Tomato juice does not come within the scope of the directive as it is not deemed to be a fruit.145 The fruit juice directive presents a clear example of reason two as to why the Community institutions may not wish to embark upon a comprehensive harmonisation programme for food standards. Considering the manner in which Community law evolves, each time a new horizontal legislative initiative is introduced, such as that on quantitative ingredient declarations, the related affected vertical legislation, such as the fruit juice directive, must also be altered to reflect this. These amendments add to an already piecemeal body of rules, complicating matters further for producers who must now look in several places to discover what the current rules may be. This difficulty is not helped by a poor track record of consolidation exercises for such legislation. 136 Preamble 8 to Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption. [2002] OJ L 10/58. 137 Annex I to Directive 2001/112. 138 Article 3(7). 139 Annex I to Directive 2001/112. 140 Article 2. 141 Article 3(2). 142 Article 3(3). 143 Ibid. 144 Article 3(4). 145 Annex II to Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption. [2002] OJ L 10/58.

(D) MacMaolin Ch3

9/2/07

15:16

Page 99

3.5 Food Names 99 Honey In 2001 a new directive146 was introduced to replace the original legislation regulating the production of honey.147 This legislation offers a rare example of a ‘recipe law’ that was not amended at any stage between its introduction and eventual repeal and replacement 27 years later. The sales name ‘honey’ can only be used where the product is: the natural sweet substance produced by Apis mellifera bees from the nectar of plants or from secretions of living parts of plants or excretions of plant-sucking insects on the living parts of plants, which the bees collect, transform by combining with specific substances of their own, deposit, dehydrate, store and leave in honeycombs to ripen and mature.148

The directive breaks down the simple definition of honey further into different honey types. The main types of honey are: blossom honey or nectar honey, which is the honey obtained from the nectar of plants; honeydew honey, which is that obtained mainly from excretions of plant-sucking insects on the living part of plants or secretions of living parts of plants; comb honey, which is the honey stored by bees in the cells of freshly built broodless combs or thin comb foundation sheets made solely of beeswax and sold in sealed whole combs or sections of such combs; chunk honey or cut comb in honey, which contains one or more pieces of comb honey; drained honey, which is obtained by draining decapped broodless combs; extracted honey, which is obtained by centrifuging decapped broodless combs; pressed honey, which is obtained by pressing broodless combs with or without the application of moderate heat not exceeding 45°C; and filtered honey, which is obtained by removing foreign inorganic matter in such a way as to result in the significant removal of pollen.149 In addition to these types of honey, the directive also stipulates the designation ‘baker’s honey’ for that which is suitable for industrial uses, or as an ingredient in other foodstuffs which are then processed and may have a foreign taste or odour, or have begun to ferment or have fermented, or have been overheated.150 The name ‘honey’ may only be used where the product meets the compositional requirements set out in the Directive.151 This

146

Council Directive 2001/110/EC of 20 December 2001 relating to honey. [2002] OJ L 10/47. Council Directive 1974/409/EC of 22 July 1974 on the harmonisation of the laws of the Member States relating to honey. [1974] OJ L 221/10. 148 Annex I to Council Directive 2001/110/EC of 20 December 2001 relating to honey. [2002] OJ L 10/47. The definition of ‘honey’ under Directive 1974/409/EEC, which was almost identical to that in the 2001 legislation, was set out in the actual text of the directive itself, Art 1(1). This is a common feature of this new wave of directives introduced since the late 1990s to replace the original ‘recipe laws’. Definitions previously set out in the main body of the legislation have now been removed to the Annex to it. 149 Annex I to Council Directive 2001/110/EC of 20 December 2001 relating to honey. [2002] OJ L 10/47. 150 Annex I to Council Directive 2001/110/EC of 20 December 2001 relating to honey. [2002] OJ L 10/47. 151 Article 2(1). 147

(D) MacMaolin Ch3

9/2/07

15:16

Page 100

100 Harmonising Food Standards in the EU also applies, where honey is described as being of a certain kind or type.152 However, these names may be replaced by the simple product name ‘honey’, except in the case of filtered honey, comb honey, chunk honey or cut comb in honey and, obviously, baker’s honey.153 In the case of baker’s honey the words ‘intended for cooking only’ must appear on the product label in close proximity to the product name.154 Where baker’s honey has been used as an ingredient in a compound foodstuff, the term ‘honey’ may be used in the product name of the compound food instead of the term ‘baker’s honey’. However, the list of ingredients must state that baker’s honey has in fact been used.155 The country or countries of origin, where the honey has been harvested, must also be stated on the label. However, if the honey originates in more than one Member State or third country then that indication may be replaced with either ‘blend of EC honeys’, ‘blend of non-EC honeys’, or ‘blend of EC and non-EC honeys’ as appropriate.156 Specific compositional criteria for honey are also set out in the directive. It is stated that honey: consists essentially of different sugars, predominantly fructose and glucose as well as other substances such as organic acids, enzymes and solid particles derived from honey collection; varies in colour from nearly colourless to dark brown; can be fluid, viscous or partly or entirely crystallised in consistency; has a varied flavour and aroma but should be derived from the plant origin; should not have added to it any food ingredient, including food additives, nor any other additions other than honey; should not have removed from it any pollen or constituent particular to honey except where this is unavoidable in the removal of foreign inorganic or organic matter; should be free from organic or inorganic matters foreign to its composition; and with the exception of baker’s honey, should not have any foreign tastes or odours, nor have begun to ferment, nor have an artificially changed acidity nor have been heated in such a way that the natural enzymes have been either destroyed or significantly inactivated.157 The quantities of, inter alia, sugar, including fructose, glucose and sucrose, and moisture content are also specified.158 The 1974 honey directive failed to set out any substantive monitoring procedure to ensure compliance with its terms. The 2001 directive also fails to do this. It simply states that methods may be adopted by the Commission, assisted by the Standing Committee on Foodstuffs, to permit verification of compliance of honey with the provisions of the legislation.159 Until the adoption of such methods Member States are, wherever possible, to use internationally recognised validated 152 153 154 155 156 157

Article 2(2). Ibid. Ibid. Article 2(3). Article 2(4). Annex II to Council Directive 2001/110/EC of 20 December 2001 relating to honey. [2002] OJ L

10/47. 158 159

Ibid. Article 7(1).

(D) MacMaolin Ch3

9/2/07

15:16

Page 101

3.5 Food Names 101 methods, such as those approved by the Codex Alimentarius, to verify compliance with the terms of the honey directive.160 The provisions of the honey directive clearly demonstrate another of the inherent difficulties that exist when the Community attempts to set harmonised food standards—compliance. In an international legal system like the EU, the Member States have to take responsibility for this through the implementation of national measures, ensuring, for example, that only those products that possess the key characteristics of the product in question may be labelled accordingly. The Commission also has a role to play here, albeit a necessarily lesser one. This does not have to be a problem in itself, as the directive does give guidance to the Member States in this regard. They are to follow internationally recognised methods for verification. The Codex Standard for Honey sets common guidelines for methods of sampling and analysis to establish compliance with compositional standards.161 This includes details of how moisture, sugar and other solid content is to be verified. Origin claims are not accounted for in these standards. Directive 2001/110 does state that the country of origin, or countries or regions where there is a blend, must be given. However, nowhere in the legislation is it stated that the percentage quantity of each variety contained in the blend must be clearly labelled. This means, for example, that a product can be labelled ‘Irish Honey’, or even ‘Pure Irish Honey’, if it is actually a blend of Irish and non-EU honeys, harvested in any number of countries. While it must state elsewhere on the label that the product is a blend of Irish and non-EU honeys, the actual content of the product harvested in Ireland could be as little as one per cent. It is ‘pure’ simply because it is 100 per cent honey, not because it is 100 per cent Irish. Where specific food standards like this have been introduced at both EU and international levels, sufficient attention should be paid to inconsistencies such as that outlined above to ensure that consumers are protected and that fair trading is facilitated. The inclusion of specific provision in this regard in the Community secondary legislation, or an extension of the quantitative ingredient declaration system to labelling disclosures such as this, could assist here. This would oblige information to be given as to the proportions of the product originating in different regions where there is a blend of ingredients, and where a specific place of origin claim is made on the label. Essentially, the EU standards exist in order to maintain a degree of harmonisation with global standards where these exist, rather than to create any meaningful level of consumer protection provision or to ensure that trade in these foodstuffs remains fair. This is examined in more detail in Chapter 4. Jams One final example of a recipe law that was introduced and later updated is that regulating the production and marketing of fruit jams, jellies, marmalades and 160 161

Article 4. Codex Standard 12/1981; revised 1987 and 2001.

(D) MacMaolin Ch3

9/2/07

15:16

Page 102

102 Harmonising Food Standards in the EU sweetened chestnut purée.162 The new fruit jams directive, which was introduced to replace the original rules,163 was part of the continuing process of simplifying and improving the accessibility of Community food rules, in particular to account for the many alterations that had taken place since the introduction of the earlier directive relating to colourings, sweeteners and other additives.164 As with the other recipe laws, the directive defines its subject and all permissible variations of it, sets out the compositional requirements for each, and specifies a set of labelling requirements for products marketed under its terms. The few EU ‘recipe laws’ that do exist have proved to be problematic, controversial and, in many ways, unable to satisfy the purposes for which they were introduced. Despite this, it is here contended that expanding this system of rules, creating more specific standards for some of the more contentious foodstuffs, such as those that have been the subject of Court examination, as discussed in Chapter 2, could now appease many of the criticisms levelled at the jurisprudence of the Court in Article 28 EC related case law. In particular, this could address aspects of the difficulties arising out of the Cassis inspired ‘race to the bottom’ where quality standards and the nutritional value of food are concerned. One major legislative initiative that has been introduced to counter claims about how the decisions of the Court of Justice contribute to an overall reduction in food quality and safety standards has been the creation of a scheme designed to protect the reputation and characteristics of geographical foodstuffs.

3.5.2 Protected Geographical Indications and Designations of Origin Originally, EU legislation containing provisions for the protection of geographical indications and designations of origin was contained in Regulation 2081/1992.165 In March 2006 a new Council Regulation was introduced, which substantially repeals and re-enacts the same provisions, but which introduces new stipulations facilitating third countries that wish to avail themselves of the protections afforded.166 These new stipulations were introduced as a consequence of the recommendations of the Dispute Settlement Body of the WTO.167 It is necessary to refer here to the motives behind the introduction of the original legislation. Primarily, it was felt that devising a scheme such as this could 162 Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption. [2002] OJ L 10/67. 163 Council Directive 1979/693/EEC of 24 July 1979 on the approximation of the laws of the Member States relating to fruit jams, jellies and marmalades and chestnut purée. [1979] OJ L 205/5. 164 Preamble 4 to Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption. [2002] OJ L 10/67. 165 Council Regulation (EEC) No 2081/1992 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [1992] OJ L 208/1. 166 Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [2006] OJ L 93/12. 167 WTO DS 174 and DS 290, EC—Trademarks and Geographical Indications.

(D) MacMaolin Ch3

9/2/07

15:16

Page 103

3.5 Food Names 103 help to satisfy the interests of the increasing number of consumers who were becoming more interested in food quality levels. A scheme designed to protect eligible foodstuffs could be used to distinguish those products that possess certain unique characteristics due to their region and/or method of production. It was also felt that the promotion of products having certain characteristics pertaining to their method and region of production could be of considerable benefit to rural economies, in particular those of less-favoured or remote areas, by improving the incomes of farmers and by retaining the rural population in these areas.168 Member States had already begun to introduce ‘registered designations of origin’, which had proved successful with producers—who secured higher incomes in return for improved quality, and with consumers—who could purchase high quality products with guarantees as to their method of production and origin. Ultimately, however, it was the diversity in the national practices for implementing registered designations of origin and geographical indications that led to the introduction of the regulation, designed to harmonise the disparate registration processes and to regain Community control. Regulation 510/2006 Regulation 510/2006, which does not apply to wines or spirits,169 lays down rules for registration as a protected geographical food name. A designation of origin is: the name of a region, a specific place or, in exceptional cases, a country, used to describe an agricultural product or a foodstuff originating in that region, specific place or country, and the quality or characteristics of which are essentially or exclusively due to a particular geographical environment with its inherent natural and human factors, and the production, processing and preparation of which take place in the defined geographical area.170

A geographical indication is: the name of a region, a specific place or, in exceptional cases, a country, used to describe an agricultural product or foodstuff originating in that region, specific place or country, and which possesses a specific quality, reputation or other characteristics attributable to that geographical origin and the production and/or processing and/or preparation of which take place in the defined geographical area.171

Food names that have become generic may not be registered as either protected designations of origin or protected geographical indications.172 A name is deemed to have become generic for the purposes of the regulation where, although it relates to the place or the region where the agricultural product or foodstuff was originally produced or marketed, it has become the common name for that 168 169 170 171 172

Preamble 3-6 to Regulation 2081/1992. Article 1(1) of Regulation 510/2006. Article 2(1)(a). Article 2(1)(b). Article 3(1).

(D) MacMaolin Ch3

9/2/07

15:16

Page 104

104 Harmonising Food Standards in the EU agricultural product or foodstuff.173 In order to establish whether a name has become generic, account is to be taken of all factors, in particular the existing situation in the Member State in which the name originates and in areas of consumption, the existing situation in other Member States, and the relevant national or Community laws.174 To be eligible to use a protected designation of origin or a protected geographical indication, an agricultural product or foodstuff must comply with the criteria for a registered specification.175 This specification should include the name of the agricultural product or foodstuff, including designation of origin or the geographical indication; a description of the agricultural product or foodstuff including the raw materials, if appropriate, and principal physical, chemical, microbiological and/or organoleptic characteristics of the product or the foodstuff; the definition of the geographical area; evidence that the agricultural product or foodstuff originates in the geographical area; a description of the method of obtaining the agricultural product or foodstuff and, if appropriate, the authentic and unvarying local methods; the details bearing out the link with the geographical environment or the geographical origin, whichever is applicable; details of the inspection structures ensuring that agricultural product and foodstuffs bearing a protected name meet the requirement laid down in the specifications; the specific labelling details relating to the protected geographical indication or protected designation of origin, whichever is applicable, or the equivalent traditional national indications; and any requirements laid down by Community and/or national provisions.176 Only a group or, subject to certain conditions, a natural or legal person is entitled to apply for registration under the regulation.177 A ‘group’ is deemed to be any association of producers and/or processors working with the same agricultural product or foodstuff.178 It may only apply for registration in respect of agricultural products or foodstuffs that it produces or obtains.179 The application for registration must include all the details of the product specification180 and should be sent to the authority in the Member State in which the geographical area is located.181 The Member State checks that the application is justified and forwards it to the Commission.182 If the Commission concludes that the name qualifies for protection, it publishes details of this in the Official Journal.183 Member States or third countries may object to the registration proposed within six months of the date of 173 174 175 176 177 178 179 180 181 182 183

Article 3(1). Ibid. Article 4(1). Article 4(2). Article 5(1). Ibid. Article 5(2). Article 5(3). Article 5(4). Article 5(5). Article 6(2).

(D) MacMaolin Ch3

9/2/07

15:16

Page 105

3.5 Food Names 105 publication.184 If there are no admissible objections raised the name is entered in a register kept by the Commission.185 Where an objection is deemed admissible, the Commission requests that the Member States concerned seek agreement on the matter among themselves.186 If no agreement is reached, it is then up to the Commission to make a decision.187 An objection will only be deemed admissible where the objecting Member State can show non-compliance with the terms of the regulation, that the proposed registration would jeopardise the existence of an entirely or partly identical name or trade mark or the existence of products which are legally on the market, or that the name applied for is generic.188 Names successfully registered are protected against any commercial use by products not covered by the registration insofar as those products are comparable to the products registered under that name or insofar as using the name exploits the reputation of the protected name; any misuse, imitation or evocation, even if the true origin of the product is indicated or if the protected name is translated or accompanied by an expression such as ‘style’, ‘type’, ‘method’, ‘as produced in’, ‘imitation’ or similar term; any other false or misleading indication as to the provenance, origin, nature or essential qualities of the product, on the packaging, advertising material or documents relating to the product concerned, and the packing of the product in a container liable to convey a false impression as to its origin; or any other practice liable to mislead the public as to the true origin of the product.189 Where a registered name contains the name of an agricultural product or foodstuff that is considered generic, the use of that generic name on other foodstuffs is not prohibited.190 Protected names may not become generic.191 What was previously Article 12 of Regulation 2081/1992 has been removed from Regulation 510/2006. It provided that the system for registering geographical indications and designations of origin could also be applied to agricultural products or foodstuffs from third countries, provided that the third country was able to satisfy the terms of the regulation, in particular those in relation to inspection arrangements, and that the third country concerned was prepared to provide protection equivalent to that available in the Community to corresponding 184 Article 7(1). Previously, there was no procedure expressly afforded to individuals to object to the registration of a protected geographical indication or a protected designation of origin under the terms of Regulation 2081/1992. The Court of First Instance had stated that the fact that an applicant controlled a large part of the market for which a protected designation has been registered, was not in itself enough to differentiate it from any other trader affected by the contested legislation. Further, the fact that an applicant had sent a duly substantiated statement to the competent authority of the Member State in which it was established, objecting to the registration of the name in question, an objection that was not forwarded to the Commission, was not sufficient to establish the admissibility of an individual objection. Case T-114/1999, CSR PAMPRYL v Commission [1999] ECR II-3331. The position has now been rectified by the terms of Articles 7(2) and (3) of Regulation 510/2006. 185 Article 7(4). 186 Article 7(5). 187 Ibid. 188 Article 7(3). 189 Article 13(1). 190 Ibid. 191 Article 13(2).

(D) MacMaolin Ch3

9/2/07

15:16

Page 106

106 Harmonising Food Standards in the EU agricultural products or foodstuffs coming from the Community.192 This requirement of reciprocity was central to the dispute at WTO level. While this is discussed in more detail in Chapter 4 below, it should be noted here that this ultimately led to the EU being forced to alter its rules in order to increase the level of access to applicants from third countries.193 Regulations are constantly being introduced to add names to the Register of protected designations of origin and protected geographical indications. Examples include presunto de barrancos and berenjena de almango,194 rocamadour,195 exmoor blue cheese,196 and timoleague brown pudding, limone di sorrento, chianti classico and cidre breton.197 In Belgium v Spain the Court discussed just how important protected designations of origin are.198 It was stated that Community legislation displays a general tendency to enhance the quality of products within the framework of the Common Agricultural Policy, in order to promote the reputation of those products through, inter alia, the use of designations of origin which enjoy special protection. That general tendency had become apparent in the quality wines sector. It had also emerged in relation to other agricultural products, in respect of which the Council had adopted Regulation 2081/1992. The eighth recital in the preamble to that regulation made it clear that the latter was to apply without prejudice to existing Community legislation on wines and spirits, which provides for a higher level of protection. Designations of origin fall within the scope of industrial and commercial property rights. The applicable rules are, it was noted, designed to protect those entitled to use them against improper use of those designations by third parties seeking to profit from the reputation which they have acquired. They are intended to guarantee that the product bearing them comes from a specified 192

Article 12(1). See Proposal for a Council regulation on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. COM (2005) 698. 194 Commission Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the Register of protected designations of origin and protected geographical indications provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [1996] OJ L 327/11. 195 Commission Regulation (EC) No 38/1999 of 8 January 1999 supplementing the Annex to Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [1999] OJ L 5/62. 196 Commission Regulation (EC) No 872/1999 of 27 April 1999 supplementing the Annex to Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [1999] OJ L 110/4. 197 Commission Regulation (EC) No 2446/2000 of 6 November 2000 supplementing the Annex to Regulation (EC) No 2400/1996 of 17 December 1996 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [2000] OJ L 281/12. 198 Case C-388/1995, Belgium v Spain [2000] ECR 3123. 193

(D) MacMaolin Ch3

9/2/07

15:16

Page 107

3.5 Food Names 107 geographical area and displays certain particular characteristics.199 They may enjoy a high reputation amongst consumers and constitute for producers who fulfil the conditions for using them an essential means of attracting custom.200 The Court accepted that the reputation of designations of origin depends on their image in the minds of consumers. That image in turn depends essentially on particular characteristics and more generally on the quality of the product. It is on the latter, ultimately, that the product’s reputation is based. It is, however, in relation to those products and foodstuffs that have not been registered as protected designations of origin or protected geographical indications that most controversy has arisen. In particular, there has been much debate over foodstuffs that have been deemed to be generic and thus are prohibited from benefiting from the protected status and the consequent advantages of successful registration. Regulation 510/2006 and Existing National Laws Regulation 510/2006 does not encroach in any way on existing national laws on the use of geographical food names that are not registered under the procedure set out therein and/or which fall outside the scope of the regulation. In Pistre, for example, proceedings were brought against the defendants for using labels liable to mislead consumers as to the qualities or provenance of products.201 The defendants were all French nationals who manufactured and marketed cured food. They were prosecuted for having marketed cooked meat products using a label bearing the description ‘mountain’, which they had not been authorised to make in relation to those products under French law. It was questioned whether the introduction of Regulation 2081/1992 had precluded the application of this national legislation, which appeared to be more restrictive than the domestic rules given that the Community Regulation restricted indications of provenance to products originating in a defined region. The French rules only required that the term ‘mountain’ be restricted to upland areas and areas with slopes of a certain degree of steepness and included significant derogations from the requirement that production processes be local by allowing, in particular, the main raw material of the product to come from outside the geographical area or by allowing the product to be manufactured partly outside that area. The defendants submitted that the conditions to which use of the description ‘mountain’ was subject were too loose and too flexible for that description to be regarded as a geographical indication within the meaning of the regulation. They submitted that the term was simply informative, wholly descriptive, generic and undefined. The French 199 See also Case C-47/1990, Établissements Delhaize frères et Compagnie Le Lion SA v Promalvin SA and AGE Bodegas Unidas SA [1992] ECR I-3669. 200 See, to that effect, in relation to indications of provenance, Case C-3/1991, Exportur SA v LOR SA and Confiserie du Tech SA [1992] ECR I-5529, para 28. 201 Joined Cases C-321/1994, C-322/1994, C-323/1994 and C-324/1994, Criminal proceedings against Jacques Pistre, Michèle Barthes, Yves Milhau and Didier Oberti [1997] ECR I-2343.

(D) MacMaolin Ch3

9/2/07

15:16

Page 108

108 Harmonising Food Standards in the EU Government contested that the description ‘mountain’ was a quality description, designed to promote products from mountain areas and to guarantee that certain requirements had been complied with. The Commission concurred. The Court stated that it was clear from the terms of the regulation that the protection of designations of origin and of geographical indications presupposes registration, which itself requires that there be a direct link between the quality of the product and its specific geographical origin. The Court ultimately found that the description ‘mountain’ was too remote from the substantive subject matter of the regulation for it to preclude the maintenance of the domestic French legislation. In Warsteiner, proceedings were brought against the respondent to prevent them from using the name ‘Warsteiner’ on the labels of bottles of beer which it brewed 40 kilometres from the town of Warstein.202 Domestic German legislation specifically prohibited the use of geographical indications that enjoy a particular reputation from being used unfairly to exploit this reputation. The Court was asked during the course of these proceedings whether the regulation prevented the application of a national provision prohibiting the misleading use of a simple geographical designation of source, one where there was no link between the characteristics of the product and its geographical provenance. The Court noted that it was expressly stated in the regulation that its scope was limited to designations where a link does exist between the characteristics of a foodstuff and its geographical origin. Citing the decision in Pistre, it was stated that the regulation does not prevent the application of domestic rules such as those at issue in this case. Regulation 2081/1992 was intended to ensure the uniform protection within the Community of the geographical indications which it covers. Regulation 510/2006 achieves the same effect. The original regulation introduced a requirement of Community registration so that these products could enjoy protection in every Member State. The national protection that a Member State confers on geographical designations which do not meet the conditions for registration are governed by the national law of that Member State and are confined to the territory of that Member State. In view of this it was held that the regulation in no way prevented the application of national legislation prohibiting the use of a geographical indication of source where there was no link between the characteristics of the products and its geographical provenance. Nature of Generic Food Names: The Feta Cheese Cases Controversy surrounding the eligibility of feta for protection as a designation of origin centred on three key issues.203 First, whether or not the name feta, given 202 Case C-312/1998, Schutzverband gegen Unwesen in der Wirtschaft eV v Warsteiner Brauerei Haus Cramer GmbH & Co KG [2000] ECR I-9187. 203 The events outlined here are also discussed in C MacMaoláin, ‘Eligibility Criteria for Protected Geographical Food Names’ (2006) 31 European Law Review 576. However, the discussion here also includes an assessment of how the status of products like feta cheese could be altered from protected geographical names to products of specific character in the interest of transparency, legal certainty, commercial fairness and free movement.

(D) MacMaolin Ch3

9/2/07

15:16

Page 109

3.5 Food Names 109 that it derives from an Italian and not a Greek word, and given that it contains no geographical place-name, may be registered as a Greek protected geographical name. Second, whether the geographical area that Greece submitted in its registration application was either too large (extending to almost the entire country) or too indistinct as a single region, possessing only a loosely based set of unifying climatic conditions or environmental factors, factors that were arguably shared equally with other areas where feta was produced, both within and outside of Greece. And third, and most importantly and controversially, whether the name feta had, over the course of time, become generic, and was therefore, under the terms of the registration procedure criteria, ineligible for protection as a designation of origin. In particular, decisions of the Court of Justice on this third contention focused on the extent to which the Commission had properly applied the criteria for the assessment of the generic nature of a food name, as set out in the regulation and the early case law on the matter. The issue of whether the sales name ‘feta’ had become generic first came before the Court in Denmark, Germany and France v Commission.204 The three applicant Member States brought actions under Article 230 EC for the annulment of Regulation 1107/1996 insofar as it registered feta as a protected designation of origin.205 The Court noted how in the explanatory memorandum to the proposal for a decision on the registering of feta as a protected designation of origin the Commission had indicated that, in view of all the information received, it was necessary to act with extreme caution in determining whether the name feta had become generic and therefore to gather convincing evidence to back up any decision to be taken. To that end, in April 1994 the Commission arranged for a Eurobarometer poll of nationals from all the Member States. The results of the study showed that on average, one in five citizens of the European Union had seen or heard the name feta, the majority of those who recognised the name associated it with Greek cheese, and three-quarters stated that it evoked a country or region with which the product has a connection. The Commission concluded from these results that the name had not become generic but that it continued to connote Greek origin for most of those who were familiar with it. In addition to this, the Scientific Committee for Designations of Origin, Geographical Indications and Certificates of Specific Character, as established by Commission Decision 1993/53,206 whose members are qualified experts with legal or agricultural backgrounds, and particularly with knowledge of intellectual property rights, also 204 Joined Cases C-289/1996, C-293/1996 and C-299/1996, Denmark, Germany and France v Commission [1999] ECR I-1541. 205 Commission Regulation (EC) No 1107/1996 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/1992. [1996] OJ L 148/1. For discussion of recent developments on the Article 230 EC procedure see JA Usher, ‘Direct and Individual Concern: An Effective Remedy or a Conventional Solution?’ (2003) 28 European Law Review 575; and Chapter 10 of D Chalmers, C Hadjiemmanuil, G Monti and A Tomkins, European Union Law (Cambridge, CUP, 2006). 206 Commission Decision of 21 December 1992 setting up a scientific committee for designations of origin, geographical indications and certificates of specific character. [1993] OJ L 13/16.

(D) MacMaolin Ch3

9/2/07

15:16

Page 110

110 Harmonising Food Standards in the EU expressed the view that the name feta met the conditions for registration as a protected name, unanimously finding that it was not generic. The three applicant States alleged infringement of the geographical names regulation. These contentions were based upon the fact that the name feta did not meet the conditions for registration as a protected designation of origin since the product did not originate in a region or a specific place and did not display any quality or characteristics which were essentially or exclusively due to the geographical environment, with its inherent natural and human factors, of the region or place in which it originated. They also submitted that the name was generic, thus precluding its possible registration, that it was derived from an Italian word and that it had never been reserved solely for cheese produced in Greece. This was disputed, the claim being that feta had been produced in Greece since ancient times and that the name had been used there since the 17th century when Greece was under Venetian influence. The Court made it clear here that any argument relating to the fact that the name did not relate to the place where the product that it designated originated was not, even if correct, applicable to the case. It is clear from the provisions of the regulation that registration as a protected designation of origin is still possible even where the name of the product does not emanate from a specific place-name.207 The examination here was thus restricted to an assessment of the generic, or otherwise, nature of the name feta and, in particular, whether the Commission had applied the correct procedures when determining whether that food name had become generic. As noted earlier, under the terms of the regulation, three main factors must be considered to establish whether a food name has become generic. These are: the existing situation in the Member State where the name originates and in areas of consumption; the existing situation in other Member States; and the relevant national or Community laws.208 Here, the Court considered that the Commission, in its pre-Regulation 1107/1996 deliberations, had minimised the importance to be attached to the situation existing in the Member States other than the State of origin, as is required. The Court thus concluded that the Commission had not taken account of the fact that the name feta had been used for a considerable time in Member States other than Greece, stressing that when determining whether a name is to be registered, account must be taken of the existence of products which have been legally marketed under that name in other Member States.209 As a 207 Article 2(3) of Regulation 2081/1992. This is now contained in Article 2(2) of Regulation 510/2006. 208 Article 3(1). 209 Similarly, an application, partially based on procedural grounds, for the annulment of Regulation 590/1999, [1999] OJ L 74, insofar as it registered the designation ‘spreewälder gurken’ as a protected geographical indication was examined in Case C-269/1999, Kühne [2001] ECR I-9517. The Court here found that their assessment had not revealed any matter of such a nature as to affect the validity of the Regulation. In coming to this conclusion the Court investigated whether there had been compliance with the registration process, including whether or not applications had been made in time, whether there had been any amendments to the original application, and whether it mattered that not all the ingredients of the foodstuff came from the Spreewald area.

(D) MacMaolin Ch3

9/2/07

15:16

Page 111

3.5 Food Names 111 consequence, it was determined that Regulation 1107/1996 was to be annulled to the extent to which it registered the name feta as a protected designation of origin. This deletion was later validated through the adoption of Regulation 1070/1999.210 While the Court had stopped just short of declaring that feta was definitely generic in nature, the reasoning that it put forward to annul Regulation 1107/1996 to the extent to which it registered the name as a protected designation of origin, clearly indicates that it believed that the Commission’s failure to consider the use of the name in other Member States as a determining factor in deciding whether the name had in fact become generic was likely to have influenced the outcome of those deliberations to the extent that had it been considered then feta would almost certainly have been declared a generic name. According to the Advocate General here, feta was definitely to be considered a generic name.211 Despite the findings of the Court of Justice in Denmark, Germany and France v Commission, the Commission later introduced Regulation 1829/2002, itself amending the Annex to Regulation 1107/1996, to reinstate feta on the register of protected designations of origin.212 In October 1999, the Commission conducted new research in each of the Member States on the geographical connotations of the name ‘feta’. The data gathered by this exercise demonstrated that in 12 of the then 15 Member States the production of feta was not governed by specific rules laying down precise definitions of quality, production methods or, where applicable, geographical areas of production. In Greece, however, production practices for feta cheese had been codified in increasingly specific terms since 1935. Legislation on the quality specifications to be complied with in producing feta cheese had existed in Denmark since 1963 and had been in force in the Netherlands between 1981 and 1998. A definition also appeared in the combined nomenclature.213 The production of feta was nonexistent in one Member State, Luxembourg, and had been sporadic in nine others. However, production of feta cheese was found to be substantial in four Member States. Greece had been producing it since ancient times, Denmark since the 1930s, France since 1931 and Germany since 1972. Greece was found to account for about 73 per cent of feta consumption in the Community. In addition to these statistics, the Scientific Committee for Designations of Origin, Geographical Indications and Certificates of Specific Character noted how consumers were being sold two products with different compositions and organoleptic properties, but using the same 210 Commission Regulation (EC) No 1070/1999 of 25 May 1999 amending the Annex to Regulation (EC) No 1107/1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/1992. [1999] OJ L 130. Article 1(1) of Regulation 1070/1999 states that ‘[t]he name feta is deleted from the register of protected designations of origin and geographical indications’. Article 1(3) provides that the name feta is to remain protected at national level until such time as a decision is taken in this regard. 211 Opinion of Mr Advocate General La Pergola delivered on 15 September 1998 on Joined Cases C-289/1996, C-293/1996 and C-299/1996, Denmark, Germany and France v Commission [1999] ECR I-1541. 212 Commission Regulation (EC) No 1829/2002 of 14 October 2002 amending the Annex to Regulation (EC) No 1107/1996 with regard to the name feta. [2002] OJ L 277/10. 213 Council Regulation (EEC) No 2658/1987 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff. [1987] OJ L 256/1.

(D) MacMaolin Ch3

9/2/07

15:16

Page 112

112 Harmonising Food Standards in the EU sales name. Traditional feta was made with sheep’s and/or goat’s milk using a slow filtration process. The second type was made from cow’s milk using a fast filtration process, known as ‘ultrafiltration’. Labels for feta not originating in Greece had made direct or indirect references to Greece, implying that the term was not being used as a common name without any geographical significance. It concluded unanimously that the designation was non-generic for several reasons. First, production and consumption are heavily concentrated in Greece. The products produced in other Member States, in particular Denmark, Germany and France, were primarily produced from cow’s milk, using different technology and were exported in large quantities to non-member countries. The original Greek product was dominant on the Community market. Second, there was no specific legislation or rules for the production and marketing of feta in most Member States. Only Greece and Denmark had any such legislation. These rules differed significantly, in particular in relation to the ingredients used and the method of production. Finally, Denmark had offered no satisfactory evidence to support its assertion that the name feta had become generic, with the result that it was permissible to use the name alongside the name of the country of production—in other words, to market a product called ‘Danish Feta’. Following the advisory opinion of the Scientific Committee and the data presented in its survey of consumer perceptions in the Member States, the Commission was now of the view that the overall analysis of the legal, historical, cultural, political, social, economic, scientific and technical information led to the conclusion that none of the criteria required by what is now Regulation 510/2006 to show that a name is generic had been met, and that consequently the name ‘feta’ had not become ‘the name of an agricultural product or a foodstuff which, although it relates to the place or the region where the product or foodstuff was originally produced or marketed, has become the common name’.214 The application by Greece to have feta registered as a protected designation of origin could proceed. Feta was thus re-registered as a protected designation of origin by Regulation 1829/2002.215 The annulment of this regulation was then sought by the applicants in Germany and Denmark v Commission, who claimed that the name ‘feta’ did not meet the criteria necessary for protection as a protected designation of origin set out in the regulation given that it was not a geographical designation at all and that it did not owe its quality and characteristics essentially or exclusively to any geographical environment.216 It was accepted by all the parties to the case that the name was derived from Italian and only entered into use in Greek in the 17th century. It was also accepted that the name was not one of a region, place or country and could not therefore be registered as a protected designation of origin under Article 2(2) of the regulation. It could therefore only possibly be registered under Article 2(3) 214

Article 3(1) of Regulation 510/2006. Article 1 of Regulation 1829/2002. Article 1(2) of the Regulation reinserted feta into part A of the Annex to Regulation 1107/1996. 216 Joined Cases C-462/2002 and C-466/2002, Germany and Denmark v Commission [2005] ECR 19115. 215

(D) MacMaolin Ch3

9/2/07

15:16

Page 113

3.5 Food Names 113 of the regulation, which extends the definition of designation of origin to traditional or non-geographical names which possess qualities or characteristics that are due to the environment in which they are produced. This geographical environment can, of course, under the terms of the regulation, be an entire country, provided that the defined area possesses specific natural and human factors which are capable of giving a foodstuff its specific characteristics. The area must present homogeneous natural factors which distinguish it from the areas adjoining it.217 Greek national law defining feta did not extend the areas of production to the entire Greek territory. Crete, for example, was not included in the area covered by the protected designation of origin specification. The Court of Justice, in examining whether or not this geographical area was legitimate for the purposes of the regulation, assessed the factors that had been taken into account by the Greek authorities in determining the environmental features that led to the production of a foodstuff with specific characteristics. The domestic legislation referred to the fact that feta must be produced from ‘the milk . . . from breeds of ewes and goats raised using traditional methods and adapted to the region of manufacture of the feta and the flora of that region must be the basis of their feed’.218 The key features uniting and distinguishing the region of production were the mountainous nature of the terrain, the climate and the vegetation. These factors were seen by the Court to indicate that the area did have homogeneous characteristics distinguishing it from the adjoining areas. The areas of Greece excluded from the defined area of production did not possess the same natural features. The geographical area set out in the national legislation protecting feta as a designation of origin was thus found to have been determined in an acceptable manner.219 The applicants also submitted that the quality and characteristics of feta were not essentially or exclusively due to a particular geographical environment, as required by the regulation. However, the Court noted that the preamble to the contested regulation did refer to a series of factors, such as sunshine levels, temperature changes, transhumance practice, extensive grazing and vegetation types, all of which indicated that the characteristics of the cheese were due primarily to the characteristics of its region or production, finding that the applicants had failed to demonstrate that the Commission’s assessment here was unfounded. The plea alleging infringement of Article 2 of the regulation was thus dismissed by the Court. On the second issue, of whether or not the name had become generic, Denmark claimed, and they were not contested on this point, that cheese produced from cow’s milk by non-traditional methods (such as ‘ultrafiltration’, which is a much 217

See Case 12/1974, Commission v Germany (sekt) [1975] ECR 181, para 8. Article 2(1)(e) of Greek Ministerial Order No 313025/1994. 219 The Court of First Instance has noted that defining too extensive a geographical area may, in theory at least, cause a reduction in the real value of a designation of origin which was previously restricted to a smaller geographical area, and possibly affect the specific rights of the undertakings in the smaller geographical area which use that designation. Case T-109/1997, Molkerei Grobbraunshain GmbH and Bene Nahrungsmittel GmbH v Commission [1998] ECR II-3533. 218

(D) MacMaolin Ch3

9/2/07

15:16

Page 114

114 Harmonising Food Standards in the EU faster process that the traditional Greek slow filtration method) had been imported into, and produced in, Greece until relatively recently as feta. The Court accepted that if this were to persist, it would be sufficient to render feta a generic sales name. However, it was noted that Greek national law had now codified all rules on the production and marketing of feta cheese and, as a result, such practices could no longer take place. The Court noted that it had held in Denmark, Germany and France v Commission that the fact that a product has been lawfully marketed under a name in some Member States may constitute a factor which must be taken into account in assessing whether that name has become generic within the meaning of the regulation. The Commission noted the levels of production of feta in Member States other than Greece in the preamble to the contested regulation and that a feta variant had been produced in some of these Member States since the 1930s. However, it was also noted that feta production remained, by and large, concentrated in Greece. Similarly, feta was consumed primarily in Greece. Evidence was also presented to the Court that demonstrated that in Member States other than Greece, feta was commonly marketed with labels referring to Greek cultural traditions. The Court inferred from this that consumers in those Member States therefore perceived feta as a Greek cheese, even where it had been produced in other Member States. These factors combined indicated to the Court that the name feta was not a generic food name. On examination of the status of existing legislation in the Member States, the third key factor in any determination of the generic status of a food name, the Court noted that Denmark and Greece were the only Member States to have legislation specifically relating to feta in place. The Danish legislation itself did not refer to ‘feta’ but instead to ‘Danish feta’, displaying to the Court that the original name had retained a Greek connotation. In addition to this, a convention between Austria and Greece of 1972 reserved the name feta in Austria exclusively for Greek products. It was also therefore found, on the basis of this assessment, that the existing national legislation of the Member States indicated that the name feta was not a generic name but related specifically to a Greek product. Finally, on the issue of relevant Community legislation, the Court noted that the name was used without further specification as to the Member State of origin in the combined customs nomenclature.220 However, it was stated that this system of classification applied to customs matters only and was not relevant to any assessment of industrial property rights and could not therefore be used in any examination of how the product should be defined for protected designation of origin purposes. It was also noted that the Commission had previously stated, in response to a parliamentary question, that ‘feta describes a type of cheese and is not a designation of origin’.221 However, this was also seen as unpersuasive here 220 CN Code 0406 9031 describes feta for the purposes of the Common Customs Tariff as being a cheese made from sheep’s milk in brine. Chapter 4 in Part II of Annex I to Council Regulation (EEC) No 2658/1987 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff. [1987] OJ L 256/1. 221 Question No 13/1985, [1985] OJ C 248/13.

(D) MacMaolin Ch3

9/2/07

15:16

Page 115

3.5 Food Names 115 due to the fact that there was no Community system for the protection of designations of origin and geographical indications in operation at the time. It was deemed to follow from all this, contrary to previous determinations on the matter, that ‘feta’ had not become a generic name. The Court thus found that the Commission could lawfully decide that the term had not become generic within the meaning of the regulation. Its validity could not therefore be successfully challenged on the point that the Commission had acted outside the powers conferred upon it by the terms of the regulation by registering for protected status a food name that was, or that had become, generic. The decision of the Court in Germany and Denmark v Commission raises a number of issues about the manner in which applications for recognition as a protected designation of origin may now be assessed. Specifically, the Court appears to have narrowed the definition of ‘generic food name’, so essential to any Regulation 510/2006 assessment. It is evident from the submissions made in the three feta cases that the production of this foodstuff, or at least a variant of it, has taken place in many states, both within and outside the EU, for many years. This is uncontested. These varieties of cheese have been consistently marketed as ‘feta’. For a long period, the Greek authorities took no action to prevent this practice. Indeed, even many Greek producers, despite the existence of domestic rules providing otherwise, have marketed variants of feta produced in non-traditional ways, using non-traditional ingredients. This seemingly lackadaisical application of domestic Greek law enabled other forms of feta to gain a foothold in the market, to the extent that the proportion of overall consumption of the traditional Greek product has fallen significantly in the Community since 1981. Despite the existence, and relative success of these other products, the Court has here determined that feta is so strongly, and distinguishably, associated with particular regions in Greece, that it should now be reaccorded protection under the terms of the Regulation. This legislation presents a derogation from one of the fundamental principles of Community law – the free movement of goods. As has been stated on numerous occasions, all such derogations should be limited to situations where an exceptional case can be made for them. This is not the case here. Consider, for example, the case of pasta (and possibly other generic geographical food names such as cheddar, emmenthal and edam), long considered a generic food name by the Court.222 There can be little doubt that most European consumers would, if asked, consider this foodstuff to be of Italian origin, remembering that the average consumer is considered to be reasonably well-informed, observant and circumspect.223 Italian domestic laws on the production and marketing of pasta were 222 Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285. See also Case 407/1985, Glocken GmbH and Kritzinger v USL Centro-Sud and Provincia autonoma di Bolzano [1988] ECR 4233. 223 See, for example, Case C-362/1988, GB-INNO-BM [1990] ECR I-667; Case C-238/1989, Pall [1990] ECR I-4827; Case C-126/1991, Yves Rocher [1993] ECR I-2361; Case C-315/1992, Verband Sozialer Wettbewerb [1994] ECR I-317; Case C-456/1993, Langguth [1995] ECR I-1737; Case C-470/1993, Mars [1995] ECR I-1923; Case C-210/1996, Gut Springenheide GmbH and Rudolf Tusky v Oberkreisdirektor des Kreises Steinfurt – Amt für Lebensmittelüberwachung [1998] ECR I-4657.

(D) MacMaolin Ch3

9/2/07

15:16

Page 116

116 Harmonising Food Standards in the EU in force until declared incompatible with Article 28 EC, and were not deemed to be justifiable on the basis of any consumer protection mandatory requirement or protection of health argument based on Article 30 EC.224 In addition to this, the Italian rules on pasta production placed far less of a restriction on the free movement of goods than the recognition of feta as a protected designation of origin does. Pasta could still be lawfully produced in any Member State and be marketed in Italy as pasta—it just had to have been made exclusively from durum wheat. Now feta, even though lawfully produced and marketed in many Member States for many years, often before the Community even came into existence, can only be marketed as such if produced in a defined geographical area, using exclusively local raw materials, of only one Member State—Greece. This creates a difficulty for the Court-created panacea of additional labelling disclosures that has been presented to remedy the preponderance of Article 28 EC difficulties arising where a Member State has set its own ‘recipe laws’ for the production and marketing of a particular foodstuff, in circumstances such as those presented here.225 Narrowing the interpretation of what constitutes a generic food name opens up the possibility of other foodstuffs, previously held or presumed to be generic, gaining protected status under the terms of the regulation, limiting the possibility that those products will be lawfully produced in other Member States. Given the criteria set by the regulation for testing the generic nature of a traditional foodstuff, coupled with the flexible application of these by the Court in Germany and Denmark v Commission, it is now perfectly conceivable that a similar assessment of the generic or otherwise nature of a food name such as ‘pasta’ should arrive at the conclusion that this may also now be rendered a geographical name, consequently throwing the well-established jurisprudence of the Court on much of its Article 28 EC case law into doubt. It is not here suggested that the registration system set out in the regulation is without merit. On the contrary, just such a system is required to ensure the maintenance of the reputation and quality of traditional local food products in the post-Cassis era.226 However, it is contended that an alternative, and much underused, Community mechanism already in existence could be utilised to great effect in circumstances such as those here presented. Where serious doubts about the generic nature of a foodstuff exist, registration for a certificate of character under the Regulation 509/2006 procedure could, and probably should, be sought instead, reserving use of the PDO/PGI system for those foodstuffs that clearly meet the eligibility criteria set out in Regulation 510/2006.227 224

Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285. Obvious examples of relevant case law here include: Case 27/1980, Criminal proceedings against Anton Adriaan Fietje [1980] ECR 3839; Case C-196/1989, Criminal proceedings against Enzo Nespoli and Giuseppe Crippa [1990] ECR I-3647; Case 90/1986, Criminal proceedings against Zoni [1988] ECR 4285; Case 178/1984, Commission v Germany (bier) [1987] ECR 1227. 226 Case 120/1978, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649. 227 Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed. [2006] OJ L 93/1. 225

(D) MacMaolin Ch3

9/2/07

15:16

Page 117

3.5 Food Names 117 Certificates of Specific Character: Regulation 509/2006 There have always been serious doubts over the geographical nature of the food name ‘feta’. The Court has been indecisive, changing its position on several occasions, as outlined above. The Commission has also altered its opinion, first claiming that the name was generic, stopping just short of initiating full Court proceedings against Greece for acting contrary to its Article 28 EC obligations, and then later backing calls for a declaration that feta was actually a geographical name. To attempt to prove this, it embarked upon a comprehensive assessment to determine consumer perceptions about the geographical connotations of the name. Despite this, at no stage did the Court in Germany and Denmark v Commission, or the Commission in its initial deliberations prior to the introduction of Regulation 1829/2002, assess whether the registration of feta as a traditional speciality guarantee under the terms of Regulation 509/2006, given the obvious non-geographical nature of the name of the product, would have been a more appropriate response in the circumstances. The regulation enables agricultural products and foodstuffs to obtain a certificate of specific character. Again, certain methods of production, compositional requirements and defined characteristics can all form part of the protected product specification.228 However, production need not be limited to a single defined region. The registered food name may only be used by those who comply with the registered product specification.229 These producers can operate in any Member State or third country, provided a designated inspection authority in that State is notified of this.230 Use of the certificate of character as an alternative to the protected designation of origin provides a solution to the present problem, for several reasons. Primarily, substantial doubts about the non-generic nature of feta exist. The three-point test in Regulation 510/2006 for establishing whether a food name is generic is not easily satisfied by feta cheese. Feta made from cow’s milk and feta produced in other Member States was available on the Greek market and was widely available in other Member States. In addition to this, other Member States did have national laws in place that permitted the marketing of non-Greek, non-traditional feta. There was no mention in existing Community legislation, such as the combined nomenclature, that feta had to be produced in Greece. The Commission, the Court of Justice and an Advocate General had all previously found that feta was a 228

Article 6(2). Article 12(1). 230 Article 16. The possibility of registering geographical cheese types under this system was recognised by Advocate General Saggio in his Opinion on Case C-448/1998, Criminal proceedings against Jean-Pierre Guimont [2000] ECR I-10663. In paragraph 10 thereof it was noted that ‘[t]he Community system does not provide any specific protection for the designation emmenthal; it is not a protected designation of origin within the meaning of Council Regulation (EEC) No 2081/1992 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs, and neither has any certificate of specific character been issued for it under Council Regulation (EEC) No 2082/1992 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs’ [1992] OJL 208/9. Mozzarella has been registered as a traditional speciality guarantee (TSG) under what was the Regulation 2082/1992 procedure. 229

(D) MacMaolin Ch3

9/2/07

15:16

Page 118

118 Harmonising Food Standards in the EU generic name. Feta is not even a Greek name. As a result, feta should not be able to be registered as a PDO. However, it is a product that clearly has identifiable and generally distinctive qualities. Names such as this, which do possess specific characteristics but which have also been lawfully produced and marketed in several Member States for several decades, with the non-traditional variety gaining a substantial share of the market, could instead be registered as traditional speciality guarantees. This enables production by traditional methods to continue, possibly using specific traditional ingredients, but in all Member States. The quality and characteristics of the product that led to the development of its popularity in the first place are preserved, but Community policy on free movement for goods is also protected. Were ‘feta’ to be registered as a traditional speciality guarantee, as opposed to a protected designation of origin, then a range of products, such as ‘Greek feta’, ‘Danish feta’ and even ‘Irish feta’ could appear on the marketplace. The ‘reasonably well-informed, observant and circumspect’ consumer could then distinguish between these clearly labelled, quality-maintained, but different products and choose according to personal preference. The Court of Justice has previously stated in its Article 28 EC determinations that national laws must not be used in a common market to crystallise consumer habits in any way.231 Prior to the registration of feta as a protected designation of origin, this common market and the free movement of goods that it facilitates, had led to the liberalising of trade in feta cheese to the extent that Greece had seen its share of feta production in the Community fall by nearly a quarter between 1981 and 2002. Non-registration of feta as a PDO was, in relation to the free movement of goods more generally, clearly having the desired effect. More operators had found uninhibited additional markets for their products in other Member States. Consumers were presented with additional choice. However, the Court’s recentlyfound willingness to accept the imposition of national and Community rules that are seemingly at odds with free movement policy now poses a threat to this. As a result of the ready acceptance of the debateable Commission assertion that feta is suitable for registration as a protected designation of origin, the production and marketing of a product lawfully produced and marketed in several Member States, even prior to the foundation of the Community, must now cease from 2007 onwards. Danish, German, French, and all other kinds of feta can be marketed no more. These products will now have to be remarketed throughout the Union under a different name, possibly even as ‘white cheese in brine made in Denmark/Germany/France/Another from pasteurised cow’s milk’, as the Greek authorities sought to impose on the applicants in Canadane. This now creates an additional impediment to free movement that the preponderance of Article 28 EC case law has sought to eradicate. Use of the traditional speciality guarantee registration system, available for food products in a position such as this, under the terms of the Certificates of Specific 231 See, for example, Case 170/1978, Commission v UK (wine and beer tax) [1980] ECR 417 and Case 178/1984, Commission v Germany (bier) [1987] ECR 1227.

(D) MacMaolin Ch3

9/2/07

15:16

Page 119

3.5 Food Names 119 Character Regulation, presents a possible remedy here, maintaining quality standards on the one hand, whilst simultaneously facilitating the free movement of goods on the other. This would also help to counter much of the legitimate criticism that has been levelled in the past at the decision taken by the Commission, following the judgment delivered in Cassis, that harmonised Community compositional standards need no longer be set for food products.232 In post-BSE Europe, where justifications for impediments to free movement created by both the Community institutions and the Member States are more readily accepted, previous over-reliance on this policy must now be reconsidered. Protection for Geographical Names under Regulation 510/2006 It is not just in relation to feta cheese that a level of protection has been granted in excess of that which would appear to be reasonable in the circumstances, especially considering existing Community rules on the free movement of food. In Gorgonzola, for example, proceedings were brought by the applicants for an order to prohibit the marketing in Austria of a blue cheese under the designation ‘cambozola’ and requiring cancellation of the ‘Cambozola’ trade mark.233 Regulation 1107/1996 established gorgonzola as a protected designation of origin.234 Under the terms of Regulation 510/2006, registered names are protected against any direct or indirect commercial use by products not covered by the registration, in particular where this is liable to mislead the public as to the true origin of the product, even where the actual origin is indicated.235 The Court was asked here whether it was compatible with Community law for national measures to prohibit the distribution of blue cheese under the name cambozola, even where the packaging of the product in question indicated its true origin. Gorgonzola had previously been protected under the 1951 Stresa Convention for the use of designations of origin and names of cheeses.236 The case law of the Court clearly states that such international agreements are not in contravention of the Treaty provisions on the free movement of goods, provided that the protected 232 Communication from the Commission to the Council and to the European Parliament on the completion of the internal market: Community legislation on foodstuffs. COM (85) 603 final. For criticism of this position see, in particular, O Brouwer, ‘Free movement of foodstuffs and quality requirements: has the Commission got it wrong?’ (1988) 25 Common Market Law Review 237. 233 Case C-87/1997, Consorzio per la tutela del formaggio Gorgonzola v Käserei Champignon Hofmeister GmbH & Co KG and Eduard Bracharz GmbH [1999] ECR I-1301. 234 Commission Regulation (EC) No 1107/1996 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/1992. [1996] OJ L 148/1. 235 Article 13(1). 236 The Stresa Convention 1951, or to give it its proper title the International Convention on the Use of Appellations of Origin and Denominations of Cheeses, was an international agreement on the use of designations of origin for cheese. The signatory countries, mostly now EU Member States (Austria, Denmark, France, Netherlands, Sweden, Norway, Switzerland), committed themselves to prohibiting the use of false designations of origin on their territory and to take all necessary measures to ensure the application of the Convention.

(D) MacMaolin Ch3

9/2/07

15:16

Page 120

120 Harmonising Food Standards in the EU names have not become generic in the country of origin.237 It was thus for the Court to decide whether the protection provided for the registered name gorgonzola had been breached by the use of the name cambozola, and in particular whether this name gave rise to an infringement of the regulation where it sets out to prevent any evocation of protected foodstuffs. ‘Evocation’ covers situations where the term used to designate a product incorporates part of a protected designation, so that when the consumer is confronted with the name of the product, the image triggered in his mind is that of the product whose designation is protected. The Court stated that since the product at issue was a soft blue cheese that was not dissimilar in appearance to gorgonzola, it would seem reasonable to conclude that a protected name is evoked where the term used to designate that product ends in the same two syllables, with the result that the phonetic and visual similarity between the two terms is obvious. As a consequence the Court found that the principle of the free movement of goods does not prevent Member States from taking measures designed to ensure the protection of registered designations of origin. Use of a name such as cambozola may be deemed to evoke the protected designation of origin gorgonzola, irrespective of the fact that the packaging indicated the true origin of the product. The rules on protected geographical food names can also be breached by slicing or packaging the food outside its traditional region of production. In Consorzio del Prosciutto di Parma v Asda and Hygrade Foods, it was found that parma ham, although produced in Italy, could not be labelled ‘genuine Italian parma ham’ unless each stage of the production process, including slicing and packaging, took place in the region of production.238 Parma ham is registered as a protected designation of origin.239 The product specification for parma ham specifically refers to the slicing and packaging of the product in the region of production. It should also be noted that it is only the specific food name that is registered which is protected under the terms of the regulation. In Chiciak, Chiciak and Fol criminal proceedings were brought against the defendants for marketing cheese using a protected designation of origin, époisses de bourgogne, in breach of the applicable national rules.240 The defendants did not deny that that the products manufactured by them failed to comply with the French protection provisions. They submitted, however, that they were legally entitled to use the name for their cheese on the ground that the French provisions were contrary to the regulation, claiming that the regulation reserves to the Commission the exclusive power to grant protection for designations of origin and prohibits the Member States from 237

Case C-3/1991, Exportur SA v LOR SA and Confiserie du Tech SA [1992] ECR I-5529. Case C-108/2001, Consorzio del Prosciutto di Parma and Salumificio S Rita SpA v Asda Stores Ltd and Hygrade Foods Ltd [2003] ECR I-5121. 239 Commission Regulation (EC) No 1107/1996 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/1992. [1996] OJ L 148/1. 240 Joined Cases C-129/1997 and C-130/1997, Criminal proceedings against Yvon Chiciak and Fromagerie Chiciak and Jean-Pierre Fol [1998] ECR I-3315. 238

(D) MacMaolin Ch3

9/2/07

15:16

Page 121

3.5 Food Names 121 legislating in that field. They also pointed out that they used only the name époisses, and not the full protected name époisses de bourgogne. Under the terms of Regulation 2081/1992, Member States could submit a list of those products that they wished to be afforded protected status.241 The French Government had submitted the name époisses de bourgogne and it was added to the list of protected designations of origin. However, after the name had been registered, the domestic rules regarding use of the protected name were altered to the extent that the name époisses, and not the full protected name époisses de bourgogne, was referred to throughout the amending decree. The Court stated that any alteration of an element of the product specification, such as the name of the product, could only be procured within the framework of the Community arrangements and procedures laid down by the regulation, not domestically. It was held that a Member State may not adopt provisions of national law to alter a designation of origin for which it had requested registration in accordance with the regulation. It was also found that each of the constituent parts of a compound designation of origin, such as that at issue here, are not necessarily protected, this being an issue for determination by national courts. The French Government and the Commission argued unsuccessfully that if it was only the entire name that had been protected, full protection could not be guaranteed. Compatibility of Protecting Names with Article 28 EC In Exportur, proceedings were brought against the respondents to prevent them from using the names ‘Alicante’ and ‘Jijona’, which are the names of Spanish towns, for confectionery produced in France.242 The Convention between the French Republic and the Spanish State of 27 June 1973 on the protection of designations of origin, indications of provenance and names of certain products provided that the names at issue were reserved exclusively for Spanish products or goods. Relying on this Convention, the applicants tried unsuccessfully to obtain interim relief, and subsequently an injunction, prohibiting the French undertakings from using the Spanish names in question. The applicants appealed. During the course of the appeal proceedings the Court was asked whether the provisions of the Franco-Spanish Convention protecting designations or indications of origin or provenance were in contravention of Articles 28 and 29 of the EC Treaty and, if they were, whether they could be authorised under Article 30 of the EC Treaty. The respondents claimed that there was no significant difference between the confectionery (tourons) produced in France and that in Spain, that the qualities and characteristics of the tourons were unrelated to their geographical origin and thus that the Franco-Spanish Convention was incompatible with Community law insofar as it was inhibiting the free movement of goods, relying on the judgment in Commission v Germany.243 As discussed in Chapter 2 above, 241 242 243

Article 17. Case C-3/1991, Exportur SA v LOR SA and Confiserie du Tech SA [1992] ECR I-5529. Case 12/1974, Commission v Germany (sekt) [1975] ECR 181.

(D) MacMaolin Ch3

9/2/07

15:16

Page 122

122 Harmonising Food Standards in the EU that judgment established that a Member State cannot, without infringing the provisions of Article 28 EC, use a legislative measure to reserve food names for domestic products by requiring that other Member States undertake to use names unknown to, or less highly regarded by, the public. By reason of its discriminatory nature, such legislation could not be covered by the derogation provided for in Article 30 EC. The applicants, referring to the decision in Prantl,244 contested that the protection of geographical names was only justifiable if it did not adversely affect fair and traditional use by third parties. The application of the Franco-Spanish Convention could not thus prevent them from using the names ‘turrón de jijona’ and ‘turrón de alicante’ since this use had been longstanding, consistent and fair. This argument was rejected. The Court had concluded in Prantl that an exclusive right to use a type of bottle, granted by national legislation in a Member State, could not be used as a bar to the importation of wines originating in another Member State and put in bottles of the same or similar shape in accordance with a fair and traditional practice observed in that Member State. This was seen by the Court in Exportur as relating to a different situation altogether, relating to problems attached to the reconciliation of the use of an indirect indication of national provenance with the concurrent use of an indirect indication of foreign provenance. It raises a general problem about the protection of geographical food names in one Member State, where the place from which the food name derives is actually located in another Member State. The respondents further maintained that the names ‘turrón de jijona’ and ‘turrón de alicante’ were generic names of types of products and were no longer indicative of a particular geographical provenance, claiming that the Convention could not prohibit the use in France of a Spanish name that had become generic in France. The Court disagreed, finding that where the protection afforded by a State to names indicating regions or places in its territory was justified under Article 30 EC, in this case in relation to industrial and commercial property rights, this protection could be legitimately extended to the territory of another Member State, assuming that the names in question had not acquired generic status in the country of origin. 3.6 FOOD QUALITY

Setting prerequisites for the use of a food name is one method that the Community has at its disposal to maintain the quality of food in the post-Cassis era. Another way is to set very general minimum requirements for the production and marketing of the most ubiquitous of non-legally-named foodstuffs, such as water, milk and meat. This can help to satisfy two of the key concerns of the EU when it comes to the sale of safe and wholesome food. The European Commission claims that there are two aspects to food quality. One is that foodstuffs should be 244

Case 16/1983, Criminal proceedings against Karl Prantl [1984] ECR 1299.

(D) MacMaolin Ch3

9/2/07

15:16

Page 123

3.6 Food Quality 123 free of harmful or undesirable substances, such as microbes, chemicals or other such substances used in the production process. The other is that foodstuffs should satisfy consumers’ expectations in terms of taste, or other subjective criteria.245 It also claims that the European Union’s approach to ensuring food quality reflects these two considerations. This is debatable. In addition to the ‘recipe laws’ and the rules on protected geographical names, there are other pieces of Community legislation dealing specifically with the quality of foodstuffs, setting the standards that have to be complied with before a foodstuff can be lawfully marketed under a specific designation. There is often a sizeable overlap between the areas of food labelling and quality. The majority of issues raised in this section on food quality are, to all intents and purposes, really labelling issues, in particular relating to the use of a food name. It is the level of control that is maintained over the use of a name that can often determine its quality. In reality, it is very difficult for legislators to control quality in any other way, and often even this possibility is not available as the food name may already be so generic that no meaningful control over composition can be introduced without the introduction of new recipe laws. Where no legislation relating to a specific foodstuff can be introduced, the consumer may still be afforded some level of protection under the framework food labelling directive,246 or the misleading advertising directive,247 but, considering previous case law on the matter, this will often not be the case.

3.6.1 Foodstuff Specific Quality Legislation Natural Mineral Water Directive 1980/777 sets out the requirements for marketing natural mineral water.248 The directive covers waters extracted from the ground of a Member State that come within the scope of the definition of natural mineral water set out therein.249 ‘Natural mineral water’ is defined as microbiologically wholesome water: originating in an underground water table or deposit and emerging from a spring tapped at one or more natural or bore exits. Natural mineral water can be clearly distinguished from ordinary drinking water: (a) by its nature, which is characterised by its mineral 245 European Commission Directorate General for Education and Culture, ‘Healthy Food for Europe’s Citizens: The European Union and Food Quality’ (2000), ISBN 92-828-8238-1. 246 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 247 Council Directive 1984/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising. [1984] OJ L 250/17. 248 Council Directive 1980/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters. [1980] OJ L 229/1. 249 Article 1(1).

(D) MacMaolin Ch3

9/2/07

15:16

Page 124

124 Harmonising Food Standards in the EU content, trace elements or other constituents and, where appropriate, by certain effects; and (b) by its original state, both characteristics having been preserved intact because of the underground origin of such water, which has been protected from all risk of pollution.250

The directive also covers waters extracted from the ground of a third country, imported into the Community and recognised as natural mineral waters by the responsible authority of a Member State.251 Only those waters that meet the definition set out may be marketed as natural mineral waters.252 It is up to the individual Member States to ensure that this happens.253 Where appropriate, water should be described as either ‘natural mineral water’, ‘naturally carbonated mineral water’, ‘natural mineral water fortified with gas from the spring’, or ‘carbonated natural mineral water’,254 which has had carbon dioxide of an origin other than the water table or deposit from which the water comes added to it.255 Labels on natural mineral water should also detail information on the analytical composition, giving its characteristic constituents and the place where the spring is exploited, provided this is not misleading in any way,256 and the name of the spring.257 Member States cannot demand that the country of origin be indicated where the natural mineral water comes from a spring in the Community.258 Marketing natural mineral waters from the same spring under more than one trade description is prohibited.259 Where the label or advertising of a natural mineral water includes a trade description different from the name of the spring or the place of its exploitation, this place-name or the name of the spring must be indicated in letters larger than those used for the trade description.260 Drinking water that does not come within the scope of the definitions set out in the directive can never be labelled as ‘mineral water’ or any other designation where this may be liable to cause confusion with natural mineral water.261 ‘Natural mineral water’ properly called can never, through its labelling, suggest a characteristic which the water does not possess, in particular as regards its origin, the date of the authorisation to exploit it, the results of analyses or any other similar references to guarantees of authenticity.262 All indications attributing to a natural mineral water properties relating to the prevention, treatment or cure of human illness are prohibited unless specifically permitted.263 250 251 252 253 254 255 256 257 258 259 260 261 262 263

Annex I Directive 1980/777. Article 1(2). Article 2. Ibid. Article 7(1). Annex I to Directive 1980/777. Article 8. Article 7(2). Article 7(3). Article 8(2). Article 8(3). Article 9(1). Ibid. Article 9(2).

(D) MacMaolin Ch3

9/2/07

15:16

Page 125

3.6 Food Quality 125 A series of requirements for natural mineral water are also detailed, relating to, inter alia, the addition or removal of carbon dioxide,264 disinfecting treatments,265 and substances which should not be present in the water, such as parasites, pathogenic micro-organisms and coliforms.266 Containers used for packaging natural mineral waters should be fitted with closures that are designed to avoid any possibility of adulteration or contamination.267 In Badische it was questioned whether the designation ‘natural mineral water’ can only be used, under the terms of the directive, if the product possesses properties that are favourable to human health.268 The proceedings arose after the respondent refused to recognise water from one of the applicant’s springs as natural mineral water because it did not contain specified levels of essential substances in accordance with domestic German provisions. Analysis of the water in question showed that it contained very little sodium and did not therefore satisfy the domestic German requirements on minimum levels of essential substances. The Court noted that the main definition of natural mineral water set out in the directive makes no reference to ‘properties favourable to health’. The Commission had proposed that use of the designation ‘natural mineral water’ should be dependent on the product possessing properties beneficial to health, but this was omitted from Directive 1980/777. The Annex to the directive merely states that the characteristics of natural mineral water ‘may give . . . properties favourable to health’. The Court noted that ‘properties favourable to health’ is not a term that is defined anywhere in the directive. This was interpreted as indicating that possessing properties favourable to health is merely a possible effect of the water’s characteristics, in particular if it contains a high mineral content, rather than being a defining characteristic. It was thus concluded that if the Council had wished to make the possession of properties favourable to health a compulsory characteristic of natural mineral water then the directive, which is drafted in precise and detailed terms, would have laid down rules in that respect. Member States were thus deemed to be precluded from making the recognition of water as natural mineral water dependent on its possessing properties favourable to health. Directive 2003/40 sets out the limits and labelling requirements for the constituents of mineral waters.269 Under the terms of the directive natural mineral waters that contain more than 1.5 mg/l have to bear a clear label stating this and pointing out that such products are not suitable for children under seven years of age.270 Ozone-enriched air can only be used where this treatment can be justified 264

Article 4(1). Article 4(2). 266 Article 5. 267 Article 6. 268 Case C-17/1996, Badische Erfrischungs-Getränke & Co KG v Land Baden-Württemberg [1997] ECR I-4617. 269 Commission Directive 2003/40/EC of 16 May 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters. [2003] OJ L 126/34. 270 Article 4. 265

(D) MacMaolin Ch3

9/2/07

15:16

Page 126

126 Harmonising Food Standards in the EU and does not alter the essential constituents of the water.271 This treatment must be clearly stated on the label.272 The directive also sets maximum limits for the quantity of certain constituents, such as arsenic, cadmium, lead and mercury, that may be present in natural mineral water,273 and the methods for analysing these constituents.274 Milk and Milk Products The sales name ‘milk’ is defined in Regulation 1898/1987 as ‘the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom’.275 The term ‘milk’ may, however, also be used where the product has been treated without altering its composition.276 Milk may be used in association with a word or words to designate the type, grade, origin and/or intended use of the milk, or to describe the physical treatment or any modification in composition to which it has been subjected, provided that the modification is restricted to an addition and/or withdrawal of natural milk constituents.277 ‘Milk products’ are defined in the regulation as: products derived exclusively from milk, on the understanding that substances necessary for their manufacture may be added provided that those substances are not used for the purpose of replacing, in whole or in part, any milk constituent.278

Examples of products falling into this category include cream, butter, buttermilk, cheese, whey and yoghurt.279 The origin of milk and milk products must be stated if it is not bovine.280 The implementation of Regulation 1898/1987 into the domestic law of the individual Member States was not a straightforward procedure. The main difficulty arose because individual Member States had, prior to the introduction of the regulation, provisions in place in their domestic systems prohibiting the marketing of milk substitutes and milk product substitutes. This was particularly evident in Commission v France 281 and Commission v Germany,282 as discussed in Chapter 2 above.

271

Article 5. Article 6. 273 Annex I. 274 Annex II. 275 Article 2(1) of Council Regulation (EEC) No 1898/1987 of 2 July 1987 on the protection of the designations used in marketing of milk and milk products. [1987] OJ L 182/36. 276 Article 2(1). 277 Article 2(1). 278 Article 2(2). 279 Annex to Council Regulation (EEC) No 1898/1987 of 2 July 1987 on the protection of the designations used in marketing of milk and milk products. [1987] OJ L 182/36. 280 Article 2(4). 281 Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793. 282 Case 76/1986, Commission v Germany (milk substitutes) [1989] ECR 1021. 272

(D) MacMaolin Ch3

9/2/07

15:16

Page 127

3.6 Food Quality 127 Spreadable Fats Regulation 2991/1994 sets Community standards for the production and marketing of spreadable fats.283 A series of sales descriptions are set out in the regulation pertaining to the different types of spreadable fats coming within the scope of the regulation.284 ‘Butter’ is defined as: The product with a milk-fat content of not less than 80 per cent but less than 90 per cent, a maximum water content of 16 per cent and a maximum dry non-fat milk-material content of two per cent.285

Margarine is: The product obtained from vegetable and/or animal fats with a fat content of not less than 80 per cent but less than 90 per cent.286

Variations on both of these definitions are also set out in the regulation, including that for half-fat butter, half-fat margarine and half-fat blend. The regulation applies to products which remain solid at a temperature of 20ºC and which are suitable for use as spreads.287 Again, only those products complying with the terms of the regulation can use the sales descriptions set out therein.288 Concentrated butter and margarine with a fat content of 90 per cent or more are excluded from this aspect of the regulation, as are those products the nature of which is clear from traditional usage and/or when the designation clearly describes a characteristic quality of the product.289 Products covered by this derogation include brandy butter, sherry butter or rum butter, which are sweetened alcoholic products with a minimum milk-fat content of 34 per cent, and buttercream, which is a sweetened product with a minimum milk-fat content of 22.5 per cent.290 Labelling information additional to that prescribed by the framework food labelling directive is also required under the terms of the regulation. This includes details of the specific sales description, the total percentage of fat content by weight at the time of production, the vegetable, milk or other animal fat content in decreasing order of weighted importance as a percentage by total weight at the time of production, and the percentage salt content, which must appear in a ‘particularly legible manner’ in the list of ingredients.291 The sales description may be used together with one or more terms to define the plant and/or animal species 283 Council Regulation (EC) No 2991/1994 of 5 December 1994 laying down standards for spreadable fats. [1994] OJ L 316/2. 284 Annex to Regulation 2991/1994. 285 Ibid. 286 Ibid. 287 Article 1(2). 288 Article 2(2). 289 Ibid. 290 Article 1(1) of Commission Regulation (EC) No 577/1997 of 1 April 1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products. [1997] OJ L 87/3. 291 Article 3(1).

(D) MacMaolin Ch3

9/2/07

15:16

Page 128

128 Harmonising Food Standards in the EU from which the product originates, the intended use of the product and the method of production,292 on condition that this does not contravene other Community provisions, such as those set out in Regulation 510/2006 on the protection of geographical indications and designations of origin, or Regulation 509/2006 on character certificates. The term ‘vegetable’ may be used together with the sales description provided that the product contains only fat of vegetable origin, with a tolerance of two per cent of the fat content for animal fats.293 All this information must be easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible.294 The term ‘traditional’ may be used together with the name ‘butter’ where the product is obtained directly from milk or cream.295 The cream must have been obtained from milk.296 The term ‘reduced-fat’ may be used for products with a fat content of more than 41 per cent, but not more than 62 per cent.297 The terms ‘low-fat’ or ‘light’ may be used for products with a fat content of 41 per cent or less.298 Regulation 577/1997 adds further detail to the framework set out in Regulation 2991/1994.299 The designation ‘butter’ is extended to include composite products of which an essential part is actually butter, provided that the end product contains at least 75 per cent milk fat and has been manufactured solely from butter, within the meaning of Regulation 2991/1994, and the other added ingredients mentioned in the description.300 Under the terms of Regulation 623/1998,301 composite products containing less than 75 per cent but at least 62 per cent milk fat may use the designation ‘butter’ if the product designation includes the term ‘butter preparation’ and an indication of the milk fat content, and, if the other added ingredients contain fat, the total fat content.302 In order to verify the

292

Article 3(3). Article 3(4). Article 3(5). 295 Article 4. 296 Ibid. 297 Article 5(2). 298 Ibid. 299 Commission Regulation (EC) No 577/1997 of 1 April 1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products. [1997] OJ L 87/3. 300 Article 3 of Regulation 577/1997 as amended by Article 1(1) of Commission Regulation (EC) No 623/1998 of 19 March 1998 amending Regulation (EC) No 577/1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products. [1998] OJ L 85/3. 301 Commission Regulation (EC) No 623/1998 of 19 March 1998 amending Regulation (EC) No 577/1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products. [1998] OJ L 85/3. 302 Article 3 of Regulation 577/1997 as amended by Article 1(1) of Regulation 623/1998. 293 294

(D) MacMaolin Ch3

9/2/07

15:16

Page 129

3.6 Food Quality 129 declared fat content of spreadable fats five samples are to be taken randomly from the batch, to be checked and analysed.303 Minced Meat Directive 1994/65 sets out the requirements for the production and marketing of minced meat and meat preparations.304 The protection of public health was deemed to be a major factor in the introduction of the legislation, particularly considering the potential risk presented where the meats concerned are eaten when undercooked.305 The directive sets requirements on the quality of minced meat and meat preparations, in particular by prohibiting the use of meat that does not meet standards relating to freshness, and by prohibiting the use of certain parts of slaughtered animals, certain types of animals, and those which have failed a health inspection, in minced meat. The directive does not apply to meat preparations and minced meat which is produced in retail shops or in premises adjacent to sales points with a view to sale there directly to the final consumer. These operations are to remain subject to the health checks required by national rules governing supervision of the retail trade.306 Minced meat is defined as ‘meat which has been minced into fragments or passed through a spinal-screw mincer’.307 Meat preparations are: meat . . . which has had foodstuffs, seasonings or additives added to it or which has undergone a treatment insufficient to modify the internal cellular structure of the meat and thus to cause the characteristics of the fresh meat to disappear.308

Seasonings, for the purposes of the directive, are ‘salt intended for human consumption, mustard, spices and aromatic spice extracts, aromatic herbs and aromatic extracts thereof’.309 The only animals that are permitted to be used in the production of minced meat are bovine animals, pigs, sheep and goats.310 Minced meat must have been prepared from striated muscle, except heart muscle,311 which meets the requirements of Directive 1964/433312 relating to, inter alia, freshness, place of 303 Article 2(3) of Regulation (EC) No 2181/1997 of 3 November 1997 amending Regulation (EC) No 577/1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/1994 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/1987 on the protection of designations used in the marketing of milk and milk products. [1997] OJ L 299/1. 304 Council Directive 1994/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations. [1994] OJ L 368/10. 305 Preamble to Directive 1994/65. 306 Article 1(2). 307 Article 2(2). 308 Ibid. 309 Ibid. 310 Article 3(1). 311 Ibid. 312 Council Directive 1964/433/EEC of 26 June 1964 on health problems affecting intraCommunity trade in fresh meat. [1964] OJ P 121/2012. English Special Edition, Series I, Chapter 1963–4, p 185.

(D) MacMaolin Ch3

9/2/07

15:16

Page 130

130 Harmonising Food Standards in the EU slaughter, inspection, hygiene and transport.313 All meat should be examined before being minced or cut up, with the soiled and suspect parts being removed and condemned before the meat is minced.314 Minced meat may not be obtained from scrap cuttings, scrap trimmings or mechanically recovered meat. In particular, it may not be prepared from meat deemed to be unfit for human consumption under the terms of Directive 1964/433,315 or from meat from the following parts of bovine animals, pigs, sheep or goats: muscles from the head, with the exception of the masseters, and the non-muscular part of the linea alba, the carpus and tarsus region and bone scrapings. The muscles of the diaphragm, after removal of the serosa, and of the masseters may be used only after an investigation for cysticercosis has been carried out. The fresh meat must not contain any bone fragments.316 3.7 CONCLUSION

It is arguable that the two most important decisions ever made by the EU institutions regarding food were that of the Court on mutual recognition and that of the Commission on ceasing to develop harmonised standards. The former facilitates free movement by ensuring that once a foodstuff is lawfully marketable in one Member State it must be lawfully marketable in all. The latter, however, has the potential to frustrate free movement. Member States continue to introduce national laws that deviate from the rules imposed in other Member States in order to protect consumers and/or human health. This would not be necessary if the harmonisation programme had not been dispensed with. Harmonisation gives Member States the opportunity to negotiate towards a common, acceptable standard; mutual recognition does not. Member States are compelled to accept the rules of other Member States, rules that they have had absolutely no input into. Where they are unwilling to accept the standards of others, they introduce or maintain their own, often resulting in a prohibition on the marketing of products coming from other States whose domestic rules are not similar. Ironically, it was because of the acceptance of mutual recognition and future reliance on the principles developed in the decision in Cassis that it was later felt that it was possible to dispense with the harmonisation programme for the composition of food products. While it is contended here that a form of standardisation for some foodstuffs could assist both free movement and food quality levels, the few vertical directives that do exist for specific foodstuffs are not particularly good examples of how any such legislative programme could best proceed. However, existing shortcomings have been identified here. There are perhaps three reasons arising out of this examination, other than a blinkered acceptance that the decision in Cassis presents a panacea for all free movement difficulties, which explain why the Community institutions may be reluctant to embark upon legislative intervention. These three 313 314 315 316

Article 3 of Directive 1964/433. Annex I to Directive 1994/65. Article 5 of Directive 1964/433. Annex I to Directive 1994/65.

(D) MacMaolin Ch3

9/2/07

15:16

Page 131

3.7 Conclusion 131 reasons are: the difficulty of getting 25 Member States to reach an acceptable compromise standard, the chocolate saga offering a clear example of this; the difficulties involved in ensuring compliance with this common standard, especially where clear monitoring procedures are not set out in the legislation, as is the case with the common Community standard for honey; and finally the interaction that is required between these vertical directives and existing horizontal legislation. Each time a new horizontal legislative initiative is introduced, such as that on quantitative ingredient declarations, the related affected vertical legislation, such as the fruit juice directive, must also be altered to reflect this, adding to an already dissonant body of rules. While the reasons why the institutions may not wish to legislate for specific foodstuffs are obvious, the key efforts that have been made to minimise some of the negative aspects of free movement policy for the quality and diversity of foodstuffs have failed to achieve their proper potential. Take the Community system for protecting geographical food names. The often erratic and arbitrary manner in which decisions are made on eligibility for protection and/or protection levels has left us with an unclear set of criteria to be used in assessing whether or not a food name may be registered as a protected geographical indication or designation of origin. An alternative mechanism, that relating to foodstuffs of specific character, remains under-used. This despite the fact that it appears that some of the more contentiously registered food names satisfy the criteria for this type of protection more readily. There are aspects of the Community’s harmonisation programme that have been successful. The framework food labelling legislation presents us with a clear set of principles and rules that can be easily applied throughout the EU. While there has been some confusion over the language that labelling must appear in, for the most part the instructions relating to information that must be present on food labels are simple and clear. The directive works because of this simplicity. When applying a standard throughout a club of 25 States, each with their own tastes, preferences and interests to protect, it is only through harmonising at a general level that legislative intervention can prove a success. More than any other, it is this trait that should be carried through to any further standardisation programme that may be developed to counter those negative aspects of free movement policy that continue to blight EU food law.

(D) MacMaolin Ch3

9/2/07

15:16

Page 132

(E) MacMaolin Ch4

9/2/07

15:16

Page 133

4 International Influences on EU Food Law 4.1 INTRODUCTION

T

HE INTERACTION BETWEEN the regulation of international trade and EU food law has increased significantly in recent years. In particular, since the inception of the World Trade Organization (WTO) in 1995, its agreements have been used to challenge the introduction or continuance of a number of EU rules or actions, most significantly those on the production and marketing of genetically modified organisms and protected designations of origin. Community legislators must now account for these international trading rules in the drafting of new legislation, or be open to challenge from other members before the WTO Dispute Settlement Body (DSB).1 Several of the WTO Agreements can impact upon EU food law, each of which will be considered in turn below. In addition to the General Agreement on Tariffs and Trade (GATT), the most significant of these are the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), the Agreement on Technical Barriers to Trade (TBT), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Agriculture. Essentially, where any aspect of EU food law, be it a piece of legislation, a decision of the Court of Justice or the development of a Community policy, is deemed to be contrary to an aspect of one or more of these Agreements, another WTO member can initiate the dispute resolution mechanism. Given the way in which the WTO has developed thus far, it is most likely to be the United States of America that brings such a challenge, as was the case when the EU introduced a de facto moratorium on the marketing of genetically modified food. There are two reasons for this. First, the European Union offers a lucrative marketplace for American producers, where, given the level of exposure to American popular culture, there is already a degree of familiarity with their products amongst European consumers. Second, the production and marketing of food in the United States is answerable to a very different regulatory regime than that applied in the EU. The American Food and Drug Administration (FDA) tends to be far more liberal as regards the level of evidence 1 See also C Barnard, The Substantive Law of the EU: The Four Freedoms (Oxford, OUP, 2004), pp 30–33; JHH Weiler (ed), The EU, the WTO and NAFTA: Towards a Common Law of International Trade (Oxford, OUP, 2000); and, more generally, TC Hartley, European Union Law in a Global Context (Cambridge, CUP, 2004).

(E) MacMaolin Ch4

9/2/07

15:16

Page 134

134 International Influences on EU Food Law of safety or security required to be presented prior to granting authorisation for the marketing of a new product. As a consequence, where European Union rules subject producers to more rigorous tests, or go further still and prohibit the sale of a foodstuff for precautionary reasons, this lucrative and familiar marketplace is inaccessible to others who have not been subject to the same procedure or whose products do not satisfy the standards set in the EU. In particular, where a prohibition is introduced, recourse to the DSB of the WTO may be the only option available to those whose products can be freely marketed elsewhere within the global trading system. 4.2 GLOBAL FREE TRADE: INTERNATIONAL RULES ON THE FREE MOVEMENT OF FOOD

Currently, the main external threat to the way in which the European Union regulates its food industry is the application of the WTO Agreements, challenging any new or existing EU rules. The WTO is essentially a negotiating forum. Everything it does is a result of negotiations between the members. The Uruguay Round of negotiations of the General Agreement on Tariffs and Trade, which took place from 1986-1994, ultimately resulted in the establishment of the WTO. Key to the WTO global trading system are the WTO Agreements, which can create difficulties for the European Union when it tries to implement a highly regimented regulatory regime on more controversial aspects of the food sector. For the purposes of this book, the two key Agreements that need to be examined most closely are the Agreement on the Application of Sanitary and Phytosanitary Measures and the Agreement on Trade Related Aspects of Intellectual Property Rights. The SPS Agreement sets the parameters within which members of the WTO must operate when introducing rules that inhibit free trade in any way for purposes designed to protect human health, animal health, plant health or the environment. It requires a certain level of scientific evidence supporting the member’s claim that a measure is necessary because a failure to introduce it would expose animals, plants, humans or the environment to risk. Key to ascertaining when a member has operated within these limits is an assessment of the suitability of any evidence presented supporting such action. It is this that arouses most controversy in relation to disputes, or potential disputes, under the terms of the SPS Agreement. This is discussed in more detail below. The TRIPs Agreement raises a number of issues in relation to the manner in which the European Union may protect the identity and character of many of its foodstuffs when trading with other WTO members. In particular, those elements that set rules on the protection of geographical food names need to be examined in detail here. Many foodstuffs that are European in origin, and which owe their geographical name to this fact, have been produced and marketed in other countries for decades. Examples include champagne, which is a generic name for sparkling wine in some parts of the world, but a protected name in the EU entitling only those producers in the Champagne region who produce their beverage

(E) MacMaolin Ch4

9/2/07

15:16

Page 135

4.2 Global Free Trade 135 in a particular way to use it, or parma ham, which may be freely marketed as such in Canada, despite the pig from which it was produced having never set trotter in Italy. This has obvious detrimental consequences for the producer of the original version of the product who may be protected in the EU but is not accorded protection elsewhere. Not only that, but where the producer of Canadian parma ham is operating under a trademark awarded by his own State, the Italian producer is unable to legally market his product in Canada under that name. Resolving any of these issues within the WTO system, given the nature of international trade law, and international law more generally, is not an easy task. It requires compromise amongst members who primarily seek to advance their own interests. In order to understand this more fully, a brief examination of the relevant Agreements and the mechanism for resolving international trade disputes is required. The discussion will then turn to a more detailed examination of the two key issues identified here as case studies demonstrating the difficulties that can exist where EU food law and the regulation of international trade interact.

4.2.1 WTO Agreements and EU Food Law The Agreement Establishing the WTO concludes with a series of annexes which contain the other international trade agreements and the detailed rules and procedures governing the operation of the Organization. Annex 1A contains the multilateral agreements on trade in goods, such as the Agreement on Agriculture, the Agreement on Technical Barriers to Trade and the Agreement on Subsidies and Countervailing Measures. Annex 1B contains the General Agreement on Trade in Services and Annex 1C contains the Agreement on Trade Related Aspects of Intellectual Property Rights. Annex 2 sets out the Understanding on Rules and Procedures Governing the Settlement of Disputes. Annex 3 details the Trade Policy Review Mechanism. Finally, Annex 4 contains the plurilateral trade agreements, such as the International Dairy Agreement and the International Bovine Meat Agreement. Agreement on Trade Related Aspects of Intellectual Property Rights The TRIPs Agreement is designed to promote effective and adequate protection of intellectual property rights, but also to ensure that, as far as possible, these and other measures and procedures do not themselves become barriers to legitimate international trade. Included in the scope of intellectual property rights covered by the terms of the TRIPs Agreement are copyright,2 trademarks,3 industrial designs,4

2 3 4

Part II, Section 1, Arts 9–14. Part II, Section 2, Arts 15–21. Part II, Section 4, Arts 25–26.

(E) MacMaolin Ch4

9/2/07

15:16

Page 136

136 International Influences on EU Food Law patents,5 topographies of integrated circuits,6 and, most importantly for the purposes of this book, geographical indications.7 For the purposes of the TRIPs Agreement, geographical indications are indications which identify a particular product as originating in the territory of a member, or a region or locality in that territory, where a given quality, reputation or other characteristic of that product is essentially attributable to its geographical origin.8 Members are to provide the legal means for interested parties to prevent the use of (a) any means in the designation or presentation of a good that indicates or suggests that the good in question originates in a geographical area other than the true place of origin in a manner which misleads the public as to the geographical origin of the good; and (b) any use which constitutes an act of unfair competition within the meaning of Article 10 of the Paris Convention (Stockholm Act 1967).9 If their legislation permits, or if requested by an interested party, members are to refuse or invalidate the registration of trademarks that contain or consist of a geographical indication with respect to goods not originating in their territory if the use of the trademark is likely to mislead the public as to the true place of origin.10 The TRIPs Agreement sets out additional protection for geographical indications for wines and spirits. It states that each member is to provide the legal means for interested parties to prevent the use of a geographical indication identifying either wines or spirits that do not originate in the place indicated by the geographical indication, even where the true origin of the goods is indicated or the geographical indication is used in translation or accompanied by expressions such as ‘kind’, ‘type’, ‘style’ or ‘imitation’.11 Registration of a trademark for wines or spirits which contain or consist of a geographical indication is to be refused or invalidated by a member if their legislation permits, or if requested by an interested party, where such wines or spirits are not of this origin.12 In the case of homonymous geographical indications for wines, protection is afforded to each indication, each member determining the practical conditions under which the homonymous indications in question are to be differentiated from each other, taking into account the need to ensure equitable treatment of the producers concerned and that consumers are not misled.13 In order to facilitate the protection of 5

Part II, Section 5, Arts 27–34. Part II, Section 6, Arts 35–38. 7 Part II, Section 3, Arts 22–24. 8 Article 22.1. 9 The Paris Convention for the Protection of Industrial Property was concluded in 1883, and has been revised several times since then. As of 12 February 1998, 145 States were party to the Convention. The Convention is administered by the World Intellectual Property Organization (WIPO). The Convention applies to industrial property rights, including patents, trademarks, industrial designs, utility models, trade names, indications of source, appellations of origin, and the repression of unfair competition. In respect of Parts II, III and IV of the TRIPs Agreement, WTO members are obliged to comply with Articles 1 through 12, and 19, of the latest act of the Convention, the Stockholm Act of 1967. 10 Article 22.3. 11 Article 23.1. 12 Article 23.2. 13 Ibid. 6

(E) MacMaolin Ch4

9/2/07

15:16

Page 137

4.2 Global Free Trade 137 geographical indications for wines, negotiations are to be undertaken in the Council for TRIPs concerning the establishment of a multilateral system of notification and registration of geographical indications for wines eligible for protection in those members participating in the system.14 There are some exceptions to the protection of geographical indications by the TRIPs rules. For example, members are not required to prevent the continued use of a particular geographical indication of another member identifying wines or spirits by any of its nationals who have used that indication in a continuous manner with regard to the same goods in the territory of that member for at least 10 years preceding 15 April 1994, or in good faith before 15 April 1994.15 Where a trademark has been applied for or registered in good faith by a member before the date of application of the TRIPs Agreement, or before the geographical indication became protected in its country of origin, any measures adopted to implement the section of the TRIPs Agreement on protected geographical indications do not prejudice eligibility for or the validity of the registration of a trademark, or the right to use a trademark, on the basis that this trademark is identical with, or similar to, a geographical indication.16 In addition, a member is not required to apply the TRIPs provisions in respect of geographical indications of another member where the relevant indication is identical to the term that is customary in common language as the common name for such goods in the territory of that member. Similarly, members are not required to apply the TRIPs provisions on geographical indications of another member with respect to vine products for which the relevant indication is identical to the customary name of a grape variety existing in the territory of that member at the date of entry into force of the WTO Agreement.17 There is no obligation on any member to protect geographical indications which are not, or which cease to be, protected in their country of origin or which have fallen into disuse in that country.18 However, members must be willing to enter into negotiations aimed at increasing the protection of individual geographical indications and these exceptions should not be used by members as a reason for refusing to conduct such negotiations or to conclude any bilateral or multilateral agreements, nor should any member use the exceptions to diminish the protection of geographical indications that existed in that member immediately prior to the entry into force of the WTO Agreement.19 The EU system for registering protected designations of origin and protected geographical indications had been found by the Dispute Settlement Body of the WTO to be contrary to the TRIPs Agreement. In the EC—Trademarks and Geographical Indications dispute, complaints were brought by both the United States and Australia, who claimed that Regulation 2081/1992 limited the access of 14 15 16 17 18 19

Article 23.4. Ibid. Article 24.5. Article 24.6. Article 24.9. Article 24.1 and 24.3.

(E) MacMaolin Ch4

9/2/07

15:16

Page 138

138 International Influences on EU Food Law nationals of other WTO members to the registration procedure and protections available, contrary to TRIPs Articles 2 (intellectual property conventions), 3 (national treatment), 4 (most-favoured nation treatment), 16 (trademark rights), 22 (protection of geographical indications), 24 (international geographical indications), 63 (transparency) and 65 (transitional arrangements).20 After the failure of the consultation process, the establishment of a panel was requested. Its report, which was circulated to members in March 2005, found that Regulation 2081/1992, as amended, did not provide the required level of national treatment to other WTO members’ trademark rights holders and products because: (i) registration of a geographical indication from a country outside the EU was contingent upon the government of that country adopting a system of similar protection equivalent to that established by the regulation and offering reciprocal protection to registered European geographical indications; and (ii) the Regulation 2081/1992 procedures required that applications and objections from other WTO members were to be examined and transmitted by the governments of those members, and required those governments to operate systems of product inspection similar to those carried out in the EU Member States.21 As a result, foreign nationals were not guaranteed access to the Regulation 2081/1992 procedure, unlike EU nationals. This reciprocity requirement was contrary to WTO obligations arising out of the TRIPs Agreement, in particular Article 3(1) thereof. As a direct result of the decision in this dispute, a proposal was introduced for a new amending protected geographical names regulation in December 2005.22 As discussed in Chapter 3, amendments made to Regulation 2081/1992 primarily concern the issue of registering geographical products from third countries that are members of the WTO. The offending provisions of the original regulation are deleted, and the reciprocity and equivalence requirements are removed. This new regulation came into effect in March 2006.23 Agreement on the Application of Sanitary and Phytosanitary Measures The SPS Agreement applies to all such measures that may, directly or indirectly, affect international trade. Sanitary or phytosanitary measures are defined in the Agreement as being any measure that is applied: to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms; to protect human or animal life or health within the territory of the member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; to protect human life or health 20

WTO DS 174 and DS 290, EC—Trademarks and Geographical Indications. Article 12 of Regulation 2081/1992. 22 Proposal for a Council regulation on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. COM (2005) 698. 23 Council Regulation (EEC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [2006] OJ L 93/12. 21

(E) MacMaolin Ch4

9/2/07

15:16

Page 139

4.2 Global Free Trade 139 within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests.24

The term ‘measures’ covers all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end-product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transportation of animals or plants, or with the materials necessary for their survival during transportation; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety.25 Members do have the right to take sanitary and phytosanitary measures that are necessary for the protection of human, animal or plant life or health, provided that these measures are not inconsistent with other aspects of the SPS Agreement. These measures can only be applied to the extent that they are necessary, and provided that they are based on scientific principles and are not maintained without sufficient scientific evidence to support them. They may not arbitrarily or unjustifiably discriminate between members, nor should they be applied in a manner that constitutes a disguised restriction on international trade.26 Where possible, and preferably, any measures adopted should be based on international standards, guidelines or recommendations where they exist, such as those of the FAO/WHO Codex Alimentarius Commission. Where measures do conform to these international standards they are to be considered as being consistent with the SPS Agreement and the GATT. Measures that result in a higher level of sanitary or phytosanitary protection than that which would be achieved by the application of the relevant international standards are allowed, but only where there is scientific justification for this. Members are to play a full part in the development of international standards in this area, in particular those of the Codex Alimentarius Commission, the International Office of Epizootics and the organisations operating within the framework of the Plant Protection Convention. The Committee on Sanitary and Phytosanitary Measures is to monitor the international harmonisation process and co-ordinate efforts in this regard with the relevant international organisations.27 Members should accept the sanitary or phytosanitary measures of other members as being equivalent to their own, even where these measures differ from their own or from those of other members trading in the same product, if the exporting member can objectively demonstrate to the importing member that its own measures achieve the same level and type of protection as theirs. Reasonable access 24 25 26 27

Annex A to the SPS Agreement. Ibid. Article 2. Article 3.

(E) MacMaolin Ch4

9/2/07

15:16

Page 140

140 International Influences on EU Food Law should therefore be given to the importing member to assess the efficacy of the exporter’s measures in this regard. Where possible, this should be brought a stage further by the development between members of bilateral or multilateral agreements on the recognition of equivalence of sanitary or phytosanitary measures.28 Most importantly, for a member’s sanitary or phytosanitary measures to stand up to international scrutiny, or for them to be objectively justifiable to those with whom they trade in the affected products, members must ensure that any such measures taken are based on an appropriate assessment of the risks to human, animal or plant life or health, taking into account the risk assessment techniques developed by the relevant international organisations. In the assessment of risk members are to take account of the available scientific evidence; the relevant processes and production methods; the relevant inspection, sampling and testing methods; the prevalence of specific diseases or pests; the existence of pest or disease free areas; the relevant ecological and environmental conditions; and quarantine or other treatment. In assessing the risk to animal or plant life or health and in determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, members are to take account of the relevant economic factors, including the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication of a pest or disease in the importing member; and the relative costeffectiveness of alternative approaches to limiting risks. In making such decisions on the appropriate level of protection, regard should always be had to the objective of minimising negative trade effects. In order to ensure that there is consistency in the application of sanitary or phytosanitary measures amongst members, efforts should be made to avoid arbitrary or unjustifiable distinctions in the levels of protection considered appropriate in different situations if these distinctions result in discrimination or a disguised restriction on international trade. To further this aim of harmonisation and certainty in the taking of such measures, members are to co-operate with the Committee on Sanitary and Phytosanitary Measures in order to develop relevant guidelines on this. In developing such guidelines, the Committee is to take account of all relevant factors, including the exceptional character of human health risks to which people voluntarily expose themselves. When establishing or maintaining sanitary or phytosanitary measures, members are to ensure that these are not more restrictive on trade than that which is required to achieve the appropriate level of protection, taking into account both technical and economic feasibility. A measure is not deemed to be more trade restrictive than that required unless there is another measure, reasonably available, also taking into account technical and economic feasibility, that achieves the appropriate level of protection and which is significantly less restrictive to trade. Where there is insufficient scientific evidence to support a measure, a member may provisionally adopt the measure on the basis of the available pertinent information, including information from the relevant international organisations. In such circumstances, members must seek to obtain the 28

Article 4.

(E) MacMaolin Ch4

9/2/07

15:16

Page 141

4.2 Global Free Trade 141 additional information necessary for a more objective assessment of the risk posed and review the measure accordingly within a reasonable period of time. Where a member believes that a measure introduced by another member is constraining, or has the potential to constrain, its exports, and the measure is not based on the relevant international standards, guidelines or recommendations, or where these standards, guidelines or recommendations do not exist, an explanation of the reasons for the measure may be requested and, where such a request is made, must be provided.29 Members must ensure that their sanitary or phytosanitary measures are adapted to the characteristics of the area—whether a country, part of a country, or all or parts of several countries—in which the product originates and for where the product is destined. In assessing these sanitary and phytosanitary characteristics, members are to take account of the level of specific diseases or pests, the existence of eradication or control programmes, and appropriate criteria or guidelines which may be developed by the relevant international organisations. Exporting members who claim that their territories are pest- or disease-free areas must provide evidence of this.30 Again, in preparing and applying sanitary and phytosanitary measures, members are to take account of the needs of developing country members, in particular the least-developed countries. For example, longer time frames for compliance and certain exceptions should be allowed where possible.31 The Agreement also establishes a Committee on Sanitary and Phytosanitary Measures to provide a forum for regular consultations, to improve international harmonisation of measures, and to encourage the use of international standards, guidelines or recommendations where appropriate.32 The potential for the SPS Agreement to impact upon EU food law and policy is clearly evident from the dispute that has arisen over the implementation of the genetically modified organisms moratorium. Complaints have been brought by the United States, Canada and Argentina, claiming that the actions of the EU in suspending the approval of biotech products has restricted international trade in food.33 It is also alleged that individual EU Member States have maintained national marketing and import bans on biotech products, even where their use has already been approved by Community law. At the time of going to press, the dispute panel were considering whether this action/inaction by the Community was contrary to Articles 2 (basic rights and obligations), 5 (assessment of risk and determination of the appropriate level of sanitary or phytosanitary protection), 7 (transparency) and 8 (control, inspection and approval procedures), as well as Annex B (transparency of sanitary and phytosanitary regulations) and Annex C (control, inspection and approval procedures) of the SPS Agreement.34 The panel 29

Article 5. Article 6. 31 Article 10. 32 Article 12. 33 WTO DS291, DS292 and DS293, EC—Approval and Marketing of Biotech Products. 34 The Panel Report was circulated to WTO Members on 29 September 2006. The Report had not yet been adopted by the Dispute Settlement Body on 31 October 2006. 30

(E) MacMaolin Ch4

9/2/07

15:16

Page 142

142 International Influences on EU Food Law is also examining whether the moratorium and Member State actions are contrary to aspects of the Agreement on Agriculture,35 and the Agreement on Technical Barriers to Trade.36 A decision on this has been delayed on several occasions, the request for consultations originally being made in May 2003, and the panel established in March 2004. After a series of delays, it was estimated that a final report would be presented by June 2005, then October 2005, then December 2005, then March 2006, then September 2006. Agreement on Technical Barriers to Trade All products traded between members, including agricultural products, are subject to the provisions of the TBT Agreement.37 Under the terms of the Agreement, members are to refrain from preparing, adopting or applying technical regulations that create unnecessary obstacles to international trade. Technical regulations must therefore be no more trade-restrictive than necessary to fulfil a legitimate objective. The legitimate objectives listed in the Agreement include national security requirements, prevention of deceptive practices, protection of human health or animal or plant life or health, and protection of the environment. In assessing such risks, members are to consider the available technical and scientific information, related processing technology and the intended end-uses of products.38 Technical regulations are defined in the Agreement as a: document which lays down product characteristics or their related processes and production methods . . . with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process of production method.39

Technical regulations should not be maintained if the circumstances or objectives giving rise to their adoption no longer exist or if the changed circumstances or objectives can be addressed in a less trade-restrictive manner.40 Where technical regulations are required and relevant international standards exist, or their completion is imminent, members are to use these standards as a basis for their technical regulations, except when the use of such standards would be ineffective or inappropriate for the fulfilment of the legitimate objectives pursued, for example because of fundamental climatic or geographical factors or technological problems.41 Members must also play a full part in harmonising technical regulations at the international level by assisting the appropriate international standardising bodies.42 Any member preparing, adopting or applying a technical regulation 35

Article 4 (market access). Articles 2 (preparation, adoption and application of technical regulations by central government bodies) and 5 (procedures for assessment of conformity by central government bodies). 37 Article 1.3. 38 Article 2.2. 39 Annex 1 to the TBT Agreement. 40 Article 2.3. 41 Article 2.4. 42 Article 2.6. 36

(E) MacMaolin Ch4

9/2/07

15:16

Page 143

4.2 Global Free Trade 143 which may have a significant effect on the trade of other members must, when requested by another member, explain the justification for that technical regulation. Where a technical regulation is introduced for one of the legitimate objectives listed and is in accordance with the relevant international standards, it is presumed that it does not create any unnecessary obstacle to international trade.43 Members must, as far as possible, accept the technical regulations of other members, even where they differ from their own, provided that they are satisfied that these regulations adequately fulfil the same objectives as their own.44 In particular, members must provide differential and more favourable treatment to developing country members on TBT matters. This includes recognising that developing country members should not be expected to use international standards as a basis for their technical regulations or standards which are not appropriate to their development, financial and trade needs.45 Members must ensure that their central government standardising bodies accept and comply with the Code of Good Practice for the Preparation, Adoption and Application of Standards, set out in Annex 3 to the TBT Agreement. They are to take the necessary reasonable measures as may be available to them to ensure that local government and non-governmental standardising bodies within their territories, as well as regional standardising bodies (bodies whose membership is open only to some WTO members: see Annex 1 to the TBT Agreement) of which they or one or more bodies within their territory are members, accept and comply with the Code of Good Practice.46 In addition, members are not to take measures that have the effect of requiring or encouraging such standardising bodies to act in a manner inconsistent with the Code. The obligations of members with respect to the compliance of standardising bodies with the provisions of the Code of Good Practice apply irrespective of whether or not a standardising body has accepted the Code.47 Under the terms of the Code of Good Practice for the Preparation, Adoption and Application of Standards, standardising bodies must accept many of the principles of the TBT Agreement that also apply to individual members. For example, there is to be recognition of international standards, such as those of the Codex Alimentarius; standardising bodies are not to introduce standards that create unnecessary obstacles to international trade; and standardising bodies are to contribute to the preparation of harmonised international standards. However, there are additional responsibilities placed on standardising bodies. For example, they are to avoid duplication of, or overlap with, the work of other standardising 43

Article 2.5. Article 2.7. 45 Article 12. 46 The procedures for the assessment of conformity by central government bodies, local government bodies and non-governmental bodies with the terms of the TBT Agreement are set out in Articles 5 to 9 thereof. Requirements relating to the availability of information about technical regulations, standards and conformity assessment procedures are set out in Articles 10 and 11 of the TBT Agreement. 47 Article 4.1. 44

(E) MacMaolin Ch4

9/2/07

15:16

Page 144

144 International Influences on EU Food Law bodies in the national territory or with the work of relevant international or regional standardising bodies. Standardising bodies should also, under the terms of the Code, specify standards that are based upon product requirements in terms of performance, rather than design or descriptive characteristics. The TBT Agreement also establishes a committee on technical barriers to trade. It is composed of a representative of each member and meets as necessary, but at least once a year, for the purpose of affording members the opportunity of consulting on any matters relating to the operation of the TBT Agreement. The Committee may establish working parties as appropriate to carry out further tasks or investigations.48 Where a dispute arises over the application of the TBT Agreement, a dispute panel may, either on its own initiative or at the request of one of the parties to the dispute, establish a technical expert group to assist in questions of a technical nature that may arise which require detailed consideration by experts.49 These groups are under the authority of the panel, which determines their terms of reference and detailed working procedures on a case-by-case basis.50 Agreement on Agriculture The WTO Agreement on Agriculture aims to liberalise international trade in the agricultural sector, in particular by easing access to all member markets. The Agreement attempts to achieve this by prohibiting impeding measures, such as quantitative import restrictions, minimum import prices, voluntary export restraints and discretionary import licensing.51 This is to be done by converting existing measures into ordinary customs duties. The Agreement also sets out a series of commitments to be undertaken by members regarding import and export subsidy levels. Members are to undertake to reduce these subsidies by agreed amounts. However, it is in relation to the enforcement and monitoring of this that the Agreement falls short. There is no effective procedure in place. The Agreement does provide that the implementation of commitments is to be reviewed by a Committee on Agriculture.52 However, the evidence suggests that members do not adhere to this in a manner that is conducive to achieving the stated aim of subsidy reduction. This is due to two factors. First, not all members submit the required information to the Committee regarding how they have met their agreed commitments, and second, the information that is submitted tends to be presented in a manner that is both confusing and misleading, making it difficult to establish whether set subsidy reduction targets have been met.53 48

Article 13. Article 14. 50 Annex 2 to the TBT Agreement. 51 Article 4.2. 52 Article 18. 53 See B O’Connor, ‘A Note on the Need for More Clarity in the World Trade Organization Agreement on Agriculture’ (2003) 37 Journal of World Trade 839. 49

(E) MacMaolin Ch4

9/2/07

15:16

Page 145

4.2 Global Free Trade 145 The second key shortcoming of the Agreement on Agriculture relates to the so-called ‘peace clause’, inserted into the Agreement after stalemate was reached during negotiations. This clause requests that members exercise due restraint when considering bringing a matter before the DSB.54 Essentially it is a plea to members not to bring any such action, in particular in relation to domestic support measures and export subsidies, unless absolutely necessary. In fact, some such actions are expressly ruled out by this. Overall, the Agreement on Agriculture fails to achieve its key aim, the liberalisation of trade in agricultural products. This is not to say that it is devoid of potential, however. For this to be realised, particularly the issue of domestic support and export subsidies, a more rigid monitoring and enforcement mechanism is required to ensure that the commitments undertaken are implemented. It would also be necessary to re-negotiate the ‘peace clause’ in a manner that further facilitates the possibility of resolving disputes relating to trade in agriculture.

4.2.2 Dispute Settlement at the World Trade Organization The system of dispute settlement set out in the GATT differed in many ways from that established for the WTO after the Uruguay Round negotiations. The mechanism set out in GATT Articles XXII and XXIII were primarily designed to appraise the practices of the contracting parties rather than to cast judgment on their actions. States were to give ‘sympathetic consideration’ to complaints that they were acting contrary to the terms of the Agreement. Initially there was not even a formal specific procedure for dealing with these complaints. However, from the early 1950s onwards, panels were established to investigate possible breaches of GATT rules, although their findings did not result in orders being given to states to alter their behaviour where they were found to be acting contrary to their international trade regulation obligations. Suggestions were made as to how compatibility with the terms of the GATT could be increased. Aspects of this customary procedure were later codified during the Tokyo Round negotiations in 1979, resulting in the drafting of an Understanding Regarding Notification, Consultation, Dispute Settlement and Surveillance, including an ‘Agreed Description of the Customary Practice of the GATT in the Field of Dispute Settlement’ as an Annex.55 The development of a codified system of dispute settlement had led to an increase in the use of the complaints procedure. However, this had also led to an increase in blocking the adoption of panel reports by the losing contracting party. It was identified, prior to the Uruguay Round, that the dispute settlement procedure would need to be improved and strengthened to counter this. The WTO Dispute Settlement Understanding (DSU) was thus developed to address the issue. 54

Article 13. For further discussion and analysis see AF Lowenfeld, International Economic Law (Oxford, OUP, 2002), pp 135–50 and RE Hudec, ‘GATT Dispute Settlement after the Tokyo Round: An Unfinished Business’ (1980) 13 Cornell International Law Journal 145. 55

(E) MacMaolin Ch4

9/2/07

15:16

Page 146

146 International Influences on EU Food Law Annex 2 to the WTO Agreement, the Understanding on Rules and Procedures Governing the Settlement of Disputes, details the manner in which disputes may be both heard and resolved at WTO level. The WTO’s dispute settlement system is described in the Understanding as ‘a central element in providing security and predictability to the multilateral trading system’.56 The manner in which this mechanism has developed since its initial inception under the GATT would suggest that it has, by and large, been successful in this regard. The prompt settlement of situations in which a member considers that any benefits accruing to it directly or indirectly are being impaired by measures taken by another member is clearly recognised as being essential to the effective functioning of the WTO and the maintenance of a proper balance between the rights and obligations of members.57 A solution that is mutually acceptable to the parties to a dispute and consistent with the covered agreements is preferred. In the absence of a mutually agreed solution, the first objective of the dispute settlement mechanism is to secure the withdrawal of the measures concerned if they are found to be inconsistent with the provisions of any of the covered agreements. The provision of compensation should only be resorted to if the immediate withdrawal of the measure is impracticable and as a temporary measure pending the withdrawal of the inconsistent measure. As a very last resort, the Understanding provides the claimant member with the possibility of suspending the application of concessions or other obligations under the covered agreements to the infringing party, subject to authorisation of any such measures by the DSB.58 The dispute settlement process commences with a member making a complaint against another member which it feels to be in contravention of one or more of the covered agreements. The covered agreements are listed in Appendix 1 to the Understanding and include the Agreement Establishing the WTO and the multilateral and plurilateral agreements on trade in goods. Consultation then takes place, during which members should attempt to find a satisfactory resolution to the matter. If consultation fails to settle the dispute within 60 days after the date of receipt of the request for consultation, the complaining party may request the establishment of a panel. This may also take place before the expiry of the 60 day period if the parties agree. This period is reduced to 20 days where the dispute relates to perishable goods.59 Conciliation and mediation procedures may be requested at any time by any party to a dispute in an attempt to resolve the matter. All parties to the dispute must agree to the use of these procedures. Once the procedures terminate, the complaining party may proceed with a request for the establishment of a panel. If the parties to a dispute agree, these procedures may also continue while the panel process proceeds.60

56 57 58 59 60

Article 3.2. Article 3.3. Article 3.7. Article 4. Article 5.

(E) MacMaolin Ch4

9/2/07

15:16

Page 147

4.2 Global Free Trade 147 Where the formation of a panel is requested and/or agreed by the parties to a dispute, it is to be established at the DSB meeting following the meeting at which the request first appeared as an item on the DSB agenda. Any request to establish a DSB must be made in writing, indicating whether consultations were held and identifying the specific measures at issue, providing a brief summary of the legal basis of the complaint.61 Panels are to be composed of well-qualified governmental and/or non-governmental individuals, including, inter alia, persons who have served on or presented a case to a panel or who have taught or published on international trade law or policy. They are to be independent and they cannot be citizens of members whose governments are parties to the dispute, unless the parties to the dispute agree otherwise. There are generally to be three panellists, but in some circumstances there may be five. Objections to proposed nominations to the panel may be raised by any party to the dispute: such an objection must be based on a compelling reason. When a dispute is between a developing country member and a developed country member the panel should include, where the developing member requests this, at least one panellist from a developing country member.62 Whenever feasible, a single panel may be established to examine more than one complaint on the same matter.63 Any member who has a substantial interest in a matter before a panel and having notified this interest to the DSB must be heard by and be permitted to make written submissions to the panel.64 The function of the panels is to assist the DSB in discharging its responsibilities under the Understanding and the covered agreements. Accordingly, a panel should make an objective assessment of the facts of the case and the applicability of and conformity with the relevant covered agreements, and to make such further findings as will assist the DSB in making the recommendations or in delivering the rulings provided for in these agreements. In order to achieve this, panels must meet regularly with the parties to the dispute to give them adequate opportunity to develop a mutually satisfactory solution.65 Panels have the right to seek information and technical advice from any individual or body that it deems appropriate.66 All panel deliberations are confidential.67 Following the consideration of submissions and arguments, the panel is to issue the descriptive sections of its draft report to the parties to the dispute. The parties are then invited to submit their comments on this in writing. The panel issues an interim report to the parties, including details of its overall findings and conclusions. Requests may be made to review the report at this stage, before it is circulated to all members. If no comments are received, the interim report is considered to be the final report and it is circulated to all members.68 The reports are then to 61 62 63 64 65 66 67 68

Article 6. Article 8. Article 9. Article 10. Article 11. Article 13. Article 14. Article 15.

(E) MacMaolin Ch4

9/2/07

15:16

Page 148

148 International Influences on EU Food Law be adopted by the DSB, unless it is decided otherwise or a party to the dispute formally notifies the DSB that it is appealing the decision. It may, of course, be adopted if any such appeal is unsuccessful.69 The standing Appellate Body is composed of seven persons, three of whom sit in any one case, serving in rotation. Only parties to a dispute, and not third parties, may appeal a panel report, although third parties who have notified the DSB of their substantial interest in the matter under review may make written submissions to, and be given an opportunity to be heard by, the Appellate Body. Appeals are limited to issues of law covered in the panel report and legal interpretations developed by the panel. The proceedings of the Appellate Body are confidential and their reports are drafted without the presence of the parties to the dispute and in the light of the information provided in the statements. The Appellate Body may uphold, modify or reverse the legal findings and conclusions of the dispute panel. Appellate Body reports are to be adopted by the DSB and unconditionally accepted by the parties to the dispute unless the DSB decides otherwise.70 Where a panel or the Appellate Body concludes that a measure is inconsistent with a covered agreement, it recommends that the member concerned bring the measure into conformity with that agreement. In addition to its recommendations, the panel or the Appellate Body may suggest ways in which the member concerned could implement the recommendations. Neither the panel nor the Appellate Body can add to or diminish the rights and obligations provided in the covered agreements.71 Prompt compliance with recommendations or rulings of the DSB are seen to be essential in order to ensure the effective resolution of disputes. Particular attention is to be paid in this regard to matters affecting the interests of developing country members. The member that is the subject of the ruling is to inform the DSB of its intentions in respect of the implementation of the recommendations made within 30 days of the adoption of the report. Longer periods of compliance may be permitted in some circumstances.72 Where the rulings or recommendations are not implemented within a reasonable period of time, compensation and the suspension of concessions or other obligations may be used as temporary measures to deal with the matter. However, full implementation of a recommendation is always preferred. The payment of compensation is voluntary. Where no deal on compensation is reached, the party that invoked the dispute settlement procedure may request authorisation from the DSB to suspend the application of concessions to the member concerned. Several principles should be followed by the complaining party when considering what concessions to suspend. The general principle is that concessions should be suspended in the same sector as that in which the panel or Appellate Body has found a violation. If this is not practicable, or will not be effective, then concessions may be suspended in other sectors dealt with under the Agreement that has been 69 70 71 72

Article 16. Article 17. Article 19. Article 21.

(E) MacMaolin Ch4

9/2/07

15:16

Page 149

4.2 Global Free Trade 149 violated. If this is neither practicable nor effective, and the circumstances are serious enough, then concessions that are covered by another agreement may be suspended. The level of the suspension of concessions authorised by the DSB should be equivalent to the level of violation of the Agreement. The suspension of concessions is a temporary measure and it can only be applied until the inconsistent measure has been removed, or until the member that is obliged to implement the recommendations or rulings provides a solution to the impasse, or until some form of mutually satisfactory solution is reached between the parties to the dispute.73 The Understanding includes a series of measures designed to make the dispute settlement procedure more attractive, and compliance with recommendations and/or rulings more feasible, for least-developed country members. Those disputes that involve a least-developed country member must give particular consideration to the position of such complainants or respondents. For example, members are to exercise due restraint in raising matters under the dispute settlement procedure. Complaining parties are also to exercise due restraint in asking for compensation or seeking authorisation to suspend the application of concessions pursuant to these procedures. Where a satisfactory solution is not found in the course of the consultation stage of the dispute settlement process, either the Director-General of the WTO or the Chair of the DSB is, when requested by a least-developed country member, to offer conciliation and mediation with a view to assisting the parties to settle the dispute before a request for a panel is made.74 Arbitration may be used as an alternative means of dispute settlement in some circumstances. Resort to arbitration is subject to the mutual agreement of the parties, which must also agree the procedures to be followed in their case. Other members, who are notified of arbitration in advance of the actual commencement of the process, may become party to the proceedings where the other parties agree. All parties to the proceeding must agree to abide by the arbitration award.75

4.2.3 Effect of WTO Rules on EU Food Law There can be little doubt about the fact that EU food law must now, where possible, conform to the Community’s WTO obligations. The actual impact of this should not, however, be overstated. The difficulties that arise in other areas of international law also arise in international trade regulation. Key to the proper functioning of any such international system of rules is compliance. Member selfinterest, delays in proceedings and lack of effective remedy continue to reduce the potential of the WTO dispute settlement mechanism for resolving international disagreements over non-compliance that impedes global trade in food. However, 73 74 75

Article 22. Article 24. Article 25.

(E) MacMaolin Ch4

9/2/07

15:16

Page 150

150 International Influences on EU Food Law there are also clearly circumstances in which WTO rules can affect the nature of EU food laws—ultimately obliging the Community to alter its legislation or behaviour in some way. Take, for example, the well-established system for the protection of geographical food names, as originally set out in Regulation 2081/1992.76 Here, a lack of effective access for applicants from third countries to the EU registration system for these foodstuffs led to findings that this legislation would have to be changed. An emphasis on prompt compliance with the findings of panel reports means that these alterations must be effected quickly. In such circumstances, the dispute resolution process can be judged a success. Compare this to the endless rounds of delay in making a decision on the EU moratorium on the approval and use of genetically modified organisms. Such procrastination minimises the impact of a ruling when it ultimately arrives. The facts here centre on actions that were initiated in the late 1990s, but the dispute panel report will not appear until at least late 2006. Nearly a decade will have passed between the trade-inhibiting actions of the EU and any finding in relation to the incompatibility of this action with WTO rules and obligations.77 By then, the moratorium will have been lifted. Public concern over the use of genetic modification techniques in food production that led to the moratorium and individual Member State action has already died down. The EU has not suffered as a result of its actions and no effective remedy, such as the suspension of trade concessions or fines, can be imposed. We note two final points at this stage regarding the interaction between international trade regulation and EU food law. First, increased use of the precautionary principle by the EU institutions, in other words the taking of trade-restrictive actions where a possibility of risk to human health or the environment is reasonably suspected, is likely to increase accusations that such actions are in direct conflict with WTO rules, in particular those set out in the SPS Agreement. This will definitely be the case until more transparent criteria are devised to establish when sufficient evidence that supports any such behaviour exists. This is discussed in more detail in Chapter 5. Second, the WTO negotiations and Agreements are only part of a package of international trade-related rules that affect EU food law. The well-established principles and standards of the FAO/WHO Codex Alimentarius Commission have consistently been used to shape EU food legislation and Court of Justice determinations. These have been influencing the nature of EU food law in a persuasive manner since both the corpus of EU rules and the Codex itself began to develop in the 1960s. 76 These provisions are now contained in Council Regulation 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs. [2006] OJ L 93/12. 77 As noted earlier, the Panel Report circulated on 29 September 2006 had not yet been adopted by the Dispute Settlement Body on 31 October 2006. However, it is noted here that the Report did find that the EU, by applying the moratorium, had acted contrary to its SPS obligations, in particular Article 8 (Control, Inspection and Approval Procedures) thereof. It was also found that the national marketing and import bans imposed by individual EU Member States were inconsistent with the essential risk assessment criteria set out in Articles 2.2. and 5.1. of the SPS Agreement.

(E) MacMaolin Ch4

9/2/07

15:16

Page 151

4.3 FAO/WHO Codex Alimentarius 151 4.3 FAO/WHO CODEX ALIMENTARIUS

The Codex Alimentarius (food code) is the seminal global reference point for food standards. UN Resolution 39/248 stipulates that the Codex should be taken into account and, where possible, transposed by States into their domestic laws on food standards. The importance and relevance of the Codex has increased significantly since the formation of regional trade areas, such as the EU, and since the inception of the WTO. Both the SPS Agreement and the TBT Agreement encourage harmonised international food standards. Both have chosen the standards, guidelines and recommendations established by the Codex Alimentarius Commission. The SPS Agreement adopts Codex standards for food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines on hygienic practice. Article 2 of the TBT Agreement states that members of the WTO are to use international standards, such as those of the Codex Alimentarius, where they exist, as a basis for their own technical regulations.78 This is also the case in situations where no such standards exist but their completion is imminent.79 As a consequence, Codex standards have become the benchmark for European Union decisions and measures on international trade in food, forming the basis for the specific requirements of many Community regulations and directives. They have also been adopted by the North American Free Trade Agreement (NAFTA), the Southern Common Market (MERCOSUR), and the Asia-Pacific Economic Co-operation Council (APEC).

4.3.1 Historical Development of the Codex Alimentarius The idea behind the FAO/WHO Codex Alimentarius came from a system of food codes used in the Austro-Hungarian Empire between 1897 and 1911. This system established a collection of standards and product descriptions for a wide variety of foods. It was known as the Codex Alimentarius Austriacus. Although it lacked true legal force, this system was used extensively as a reference resource by courts to determine the typical standards for or identity of a particular foodstuff. The FAO/WHO Codex Alimentarius, which takes its name from the Austrian code, was initiated in 1961. Among the first foodstuffs to be standardised by the code in 1966 were cheddar, edam and gouda, followed by emmenthal in 1967, and cottage cheese and saint paulin in 1968. Among the more recent foodstuffs to be standardised through the Codex are fruit juices (2005),80 oranges (2004),81 and canned bamboo shoots (2003).82 The two main purposes behind the formulation of a global food 78 Article 2.4 of the TBT Agreement. The Codex Alimentarius is not specifically mentioned but it is clear that it is this type of international harmonised standard to which the TBT Agreement alludes. 79 Article 2.4 of the TBT Agreement. 80 Codex Standard 247/2005. 81 Codex Standard 245/2004. 82 Codex Standard 241/2003.

(E) MacMaolin Ch4

9/2/07

15:16

Page 152

152 International Influences on EU Food Law standards code are food security and consumer protection.83 However, the remit of the Codex Alimentarius Commission has evolved with the development of the Codex itself. The Codex now covers standards relating to food composition, codes of hygiene and technological practice, evaluation and limitation of the use of pesticides, guidelines on contaminants, and the evaluation of additives and veterinary drugs. Among some of the standards set by the Codex are those on the analysis of contaminants and pesticides, maximum levels for toxins in milk, cadmium in cereals and lead in foodstuffs, the collection, processing and marketing of natural mineral waters and the transportation of food in bulk. The Codex also sets an international numbering system for additives. Codex standards may be fully accepted, accepted with minor deviations, or accepted by ‘free distribution’ by the member countries. The FAO and the WHO provide assistance to developing countries to ensure that they have the technical and administrative infrastructure in place to enable them to adopt Codex standards. Such assistance includes convening expert meetings to advise the Codex Alimentarius Commission on relevant issues, conducting workshops and training courses, strengthening analysis and inspection capabilities, and assisting in the establishment of food control agencies. The other key accomplishment of the Codex is that food hazards and the importance of quality in food have been put in the spotlight. Through its work, the Codex Alimentarius Commission generates scientific studies and convenes expert committees, such as the Expert Committee on Food Additives and the Expert Committee on Pesticide Residues, and consultations, such as those on risk assessment and food safety (1995), biotechnology and food safety (1996), and the role of government agencies in assessing HACCP (the application of hygienic practices in food production) (1998). The Codex Commission is a useful forum for the exchange of ideas and information relating to the need for, and the identification of, best practice in the production and marketing of food globally. It has also prompted action to be taken within individual States that may otherwise have failed to act on many of the key issues. In particular, through the expansion and development of the Codex, many States have recognised the need for domestic food agencies to be created to oversee the implementation of these best practices, or at the very least, an acceptable version of them.

4.3.2 Operation of the Codex Alimentarius Commission Both the eleventh session of the Conference of the FAO in 1961 and the sixteenth World Health Assembly in 1963 passed resolutions to establish the Codex 83 Food security is deemed to exist when ‘all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life’. World Food Summit, Rome, November 1996. For further discussion see K Mechlem, ‘Food Security and the Right to Food in the Discourse of the United Nations’ in F Snyder (ed), International Food Security and Global Legal Pluralism (Brussels, Bruylant, 2004).

(E) MacMaolin Ch4

9/2/07

15:16

Page 153

4.3 FAO/WHO Codex Alimentarius 153 Alimentarius Commission and adopted statutes and rules of procedure for the Commission. The statutes provide the legal basis for the work of the Commission. Article 1 states the purpose of the Commission, and sets out its terms of reference and objectives. It states that the Commission is: responsible for making proposals to, and shall be consulted by, the Directors-General of the FAO and the WHO on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme, the purpose of which is: (a) protecting the health of consumers and ensuring fair practices in the food trade; (b) promoting co-ordination of all food standards work undertaken by international governmental and non-governmental organisations; (c) determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organisations; (d) finalising standards elaborated under (c) above and, after acceptance by governments, publishing them in a Codex Alimentarius either as regional or world wide standards, together with international standards already finalised by other bodies under (b) above, wherever this is practicable; (e) amending published standards, after appropriate survey in the light of developments.

Article 2 defines eligibility for membership of the Commission, which is open to all member nations and associate members of the FAO and WHO. There are currently 173 members of the Codex Commission. The Rules of Procedure of the Codex Alimentarius Commission state the conditions for membership of the Commission, and provide for the appointment of Commission officers, including the chair, three vice-chairs, regional co-ordinators and a secretary, setting out the responsibilities of each; the establishment of an executive committee to meet between Commission sessions and to act on behalf of the Commission as its executive; the frequency and operation of Commission sessions; the nature of agendas for Commission sessions; voting procedures; the role of observers; preparation of Commission records and reports; the establishment of subsidiary bodies; the procedures to be adopted in the elaboration of standards; budget allocation; and the languages to be used by the Commission. The Commission meets every two years, alternating between the FAO headquarters in Rome and WHO’s headquarters in Geneva. National delegations at plenary meetings are generally led by government-appointed officials, who may be accompanied by representatives from industry and consumer organisations, and academics. International governmental and non-governmental organisations may also attend as observers. While their opinions may be heard at the meetings, they are not allowed to partake in the final decisions, which must be made exclusively by the member governments. Contact with the member governments is meant to be continuous. In order to facilitate this dialogue many members have set up Codex contact points and national Codex committees to co-ordinate and report on national activities. The Codex Alimentarius procedural manual sets out the process by which standards are prepared. First, a proposal for a standard to be developed is submitted

(E) MacMaolin Ch4

9/2/07

15:16

Page 154

154 International Influences on EU Food Law by a national government or a subsidiary committee of the Commission. Then, either the Commission or the Executive Committee decides that the proposed standard should be developed, and creates a subsidiary body under the Formal Criteria for the Establishment of Work Priorities and for the Establishment of Subsidiary Bodies, which is to be responsible for steering the standard through its development. A proposed draft standard is formalised by the Commission secretariat and circulated to the member governments for comment. These comments are considered by the subsidiary body that has been made responsible for the development of the proposed draft standard. This body may then present the text to the Commission as a draft standard. If the Commission decides to adopt the draft standard, it is sent to member governments a number of times (usually between five and eight times) in a step procedure. If the parties are satisfied, the draft becomes a Codex standard and part of the Codex Alimentarius. The established format for a Codex standard includes information relating to the name of the standard; description, essential composition and quality factors defining the minimum standard for the food; food additives (as only those accepted by the FAO and WHO may be used); contaminant details; hygiene, weights and measures details; labelling, in accordance with the Codex General Standard for the Labelling of Prepackaged Foods; and methods of analysis and sampling. Codex standards are both horizontal (applying to all foodstuffs) and vertical (applying to specific foodstuffs) in nature. Horizontal standards are set for food labelling, food additives, contaminants in food, methods of analysis and sampling, food hygiene, nutrition and foods for special dietary uses, food import and export inspection and certification systems, residues of veterinary drugs in food, and pesticide residues in food. The complete Codex is set out in volumes on: general requirements and food hygiene; pesticide residues in foods; residues of veterinary drugs in food; foods for special dietary uses (including those for babies and children); processed and quick-frozen fruits and vegetables; fresh fruit and vegetables; fruit juices; cereals, pulses (legumes) and derived products and vegetable proteins; fats and oils and related products; fish and fishery products; meat and meat products, soup and broths; sugars, cocoa products, chocolate and miscellaneous products; milk and milk products; and methods of analysis and sampling. These individual volumes are structured in sections, each dealing with individual aspects of the subject area. For example, volume 1A on general requirements is divided into eight sections on general principles, definitions, code of international trade ethics, food labelling, food additives, contaminants, irradiated foods, and food inspection and certification systems. Under its Rules of Procedure, the Codex Commission is empowered to establish two kinds of subsidiary body: Codex Committees, which prepare draft standards for submission to the Commission; and Co-ordinating Committees, through which regions or groups of countries co-ordinate food standard activities in their region, including the development of regional standards. The Codex Committees may be either general subject committees or individual commodity committees. The general subject committees deal with horizontal issues. There are existing

(E) MacMaolin Ch4

9/2/07

15:16

Page 155

4.3 FAO/WHO Codex Alimentarius 155 committees on general principles, food labelling, methods of analysis and sampling, food hygiene, pesticide residues, food additives and contaminants, import/export inspection and certification systems, nutrition and foods for special dietary uses, and veterinary drug residues. Generally, these committees are hosted by a member country, which is extensively responsible for the maintenance and administration costs of the committee and for providing its chair. Host states include France (general principles), Canada (labelling), Hungary (analysis and sampling), the United States of America (hygiene and veterinary drugs), The Netherlands (pesticides and additives and contaminants), Germany (nutrition) and Australia (inspection and certification systems). These general subject committees develop all-embracing concepts and principles applying to foods in general and specific foods or groups of foods; endorse or review relevant provisions in Codex commodity standards; and, on the basis of expert scientific advice, develop major recommendations pertaining to consumer health and safety. The commodity committees are responsible for developing standards for specific foods or classes of food, their work being vertical in nature. Again, these committees are hosted by member countries who meet much of the administrative cost of their operation. There are committees on fats and oils; sugars (both hosted by the United Kingdom); fish and fishery products (Norway); milk and milk products; meat hygiene (both New Zealand); fresh fruit and vegetables (Mexico); cocoa and chocolate; natural mineral waters; soups and broths (all by Switzerland); processed fruits and vegetables; cereals, pulses and legumes (both by the United States of America); vegetable proteins (Canada); and processed meat and poultry products (Denmark). The Commodity Committees convene as necessary. They go into recess or are abolished once the Commission feels that their work is complete. New committees may be established on an ad hoc basis to cover specific needs and develop new standards as necessary. The co-ordinating committees have no standing host country. Meetings are hosted by countries of a region, usually a continent or combination of continents, on an ad hoc basis and in agreement with the Codex Commission. There are co-ordinating committees for Africa, Asia, Europe, South America and the Caribbean, and North America and the Southwest Pacific. The reports of the coordinating committees, which must reflect regional interests, are submitted to the Codex Commission.

4.3.3 Codex Alimentarius Standards Article 1 of the FAO/WHO Codex statutes states that one of the main priorities is the protection of the health of consumers and the maintenance of fair trade practices in the food trade. Other United Nations bodies also recognise the importance of consumer protection. In 1985 a UN General Assembly resolution gave rise to the drafting of Guidelines for Consumer Protection, published in 1986. These guidelines identify food as one of three priority areas that are of essential concern to the

(E) MacMaolin Ch4

9/2/07

15:16

Page 156

156 International Influences on EU Food Law health of consumers. The document specifically identifies the Codex as the reference point for these consumer protection-related issues with regard to food. Two important international FAO/WHO conferences were held in the 1990s on food and nutrition. In 1991 the Conference on Food Standards, Chemicals in Food and Food Trade, held in co-operation with GATT, recommended continuing and strengthened consumer participation in food-related decision-making at both national and international levels. The 1992 International Conference on Nutrition recommended that consumers be protected through improved quality and safety and outlined measures designed to accomplish this. The FAO/WHO also held an expert consultation on the Integration of Consumer Interests in Food Control in 1993. The Codex standards clearly, by their very nature, offer consumers a level of protection by specifying minimum quality levels for foodstuffs. In addition to this, the Codex also sets general horizontal standards which have a direct bearing on consumer protection levels. For example, there is a General Standard for the Labelling of Prepackaged Foods, and there are the Codex General Guidelines on Claims and Codex Guidelines on Nutrition Labelling. Other general standards have a role to play in protecting the consumer too, such as those for food hygiene, food additives, contaminants and toxins in food and irradiated foods. Other, more specific standards have been set relating to consumer health protection, such as the Levels for Radionuclides in Foods Following Accidental Nuclear Contamination for Use in International Trade. The Codex also sets out a series of codes of practice, such as the Recommended International Code of Practice—General Principles of Food Hygiene and the Recommended International Code of Practice for Control of the Use of Veterinary Drugs. There are also a number of codes of technological practice which are designed to ensure that the processing, transportation and storage of foods produced to Codex standards are such that the end product that consumers receive attains the expected quality level. Such codes exist for infant foods, the transportation of fresh fruit and vegetables and the storage and transportation of edible oils and fats. The work of the Codex Alimentarius Commission is not limited to the removal of barriers to international trade. It also supports and encourages food traders to adopt voluntary ethical practices to promote fair trade. The Commission has published the Code of Ethics for International Trade in Food to aid this endeavour. Codex Alimentarius Code of Ethics The Codex Alimentarius Commission adopted the Code of Ethics for International Trade in Food at its thirteenth session in December 1979. The Code was later amended by the sixteenth session of the Commission in July 1985. The Commission recognised that adequate, safe, sound and wholesome food is vital to achieving acceptable standards of living. The right to such a standard, particularly in relation to the health and well-being of the individual, is proclaimed in the United Nations Universal Declaration of Human Rights.

(E) MacMaolin Ch4

9/2/07

15:16

Page 157

4.3 FAO/WHO Codex Alimentarius 157 Food is also vital to international trade. Food quality is influenced primarily by prevailing commercial practices, food legislation and control measures. Given that consumers spend such a significant portion of their income on food, it is important that unfair trade practices should be minimised and that the safety and wholesomeness of food should be maximised. The Commission felt it necessary to act due to underdeveloped food legislation and control infrastructures in many states, leaving them vulnerable to unethical trading practices and consequently exposed to poor quality and unsafe food imports. The Codex Alimentarius Commission was, it was claimed, particularly well placed to draft a code on this issue, given that its principal objectives include the protection of consumer health and ensuring fair practices in international trade in food, facilitating such trade through the harmonisation of standards and practice in food production. Its role, and that of the Code of Ethics, would be to assist individual members in establishing or strengthening their food legislation and food control infrastructures and, where necessary, to take advantage of the work of international organisations competent to advise and provide assistance in such matters, such as the Codex Alimentarius Commission itself. The hope was that the Code would help to establish an internationally agreed norm and a framework for the realisation of effective international co-operation on those ethical aspects of trade covered by it. In particular, the Code seeks to establish standards of ethical conduct for all those engaged in international trade in food or responsible for regulating it and thereby to protect the health of the consumer and promote fair trade practices.84 In order to achieve this, those engaged in international trade in food would have to commit themselves morally to the code and voluntarily undertake to support its implementation. The Code states that international trade in food should be conducted on the principle that all consumers are entitled to safe and wholesome food and to protection from unfair trade practices.85 Therefore, no food should be traded internationally which contains any substance in an amount that renders it poisonous or otherwise harmful to human health; consists in whole or in part of any filthy, putrid, rotten, decomposed or diseased substance or foreign matter, or is otherwise unfit for human consumption; is adulterated; is labelled or presented in a manner that is false, misleading or deceptive; or is sold, prepared, packaged, stored or transported for sale under unsanitary conditions.86 The Code also sets out a series of specific requirements on individual aspects of the production and marketing of food in international trade.87 It states that appropriate standards should be established and enforced, taking into account that uniform consumer protection and the orderly marketing of food can be better achieved through the acceptance of food standards elaborated by the Codex Alimentarius Commission or the adaptation of national standards to such international recommendations. In addition to this, food should be subject at all times 84 85 86 87

Article 1. The Code also applies, mutatis mutandis, to concessional food and food aid. Article 2.1. Article 4.1. Article 4.2. Article 5.

(E) MacMaolin Ch4

9/2/07

15:16

Page 158

158 International Influences on EU Food Law to sound hygienic practices; it should be accompanied by accurate and adequate descriptive labelling information; it should contain only Codex Alimentarius approved additives; pesticide residues and contaminants should be limited to the maximum Codex recommendations; all food should be free from microorganisms and parasites in harmful amounts; irradiated food should be produced and controlled in accordance with the provisions and standards of the Codex Alimentarius Commission; food for infants and children and other vulnerable groups should be in accordance with Codex standards; no claims should be made about any food, particularly processed food, with minimal nutritive value which implies that the food can make a valuable contribution to the diet; and any information concerning the nutritional value of food should not mislead the public. The implementation of the Ethics Code is deemed to be a matter for governments, who should provide adequate food legislation and food control infrastructures, including certification and inspection systems and other legal or administrative procedures as necessary.88 It is recognised that, in some emergency situations, such as famines, it may not be possible or desirable to apply certain provisions of the Code. However, in such circumstances, due regard should still be had to the basic principles of the safety of food and other provisions of the Code as may be applicable under those circumstances.89 Codex Alimentarius Food Labelling Standards The Codex Ethics Code sets appropriate food labelling information as one of the primary mechanisms to be used in efforts to ensure that internationally traded food is both safe and wholesome and that the consumer is protected. By obliging the producer to state the composition of a product clearly on an accompanying label there is less potential for consumer deception. Codex standards have thus been devised for labelling requirements generally,90 foods for special dietary uses,91 and individual generic food products, such as chocolate and butter.92 Guidelines have been set for nutrition labelling,93 the production and labelling of organic foods,94 and claims made on food labelling.95 It is hoped that through the international adoption of these harmonised standards consumers will be protected to the best possible level throughout the trading world.

88

Article 7. Article 8. Codex Standard 1/1985. Revised 1991 and 2005. 91 Codex Standard 146/1985. 92 Codex Standard 87/1981. Revised 2003. 93 Codex Guidelines 2/1985. Revised 1993 and 2003. 94 Codex Guidelines 32/1999. Revised 2001 and 2004. 95 General Guidelines on Claims, Codex Guidelines 1/1979, revised 1991; Guidelines for Use of Nutrition and Health Claims, Codex Guidelines 23/1997, revised 2004. 89 90

(E) MacMaolin Ch4

9/2/07

15:16

Page 159

4.3 FAO/WHO Codex Alimentarius 159 The Codex General Standard for the Labelling of Prepackaged Foods applies to all prepackaged foods, including those for catering purposes.96 Prepackaged food must not be described or presented on any labelling in a manner that is false, misleading or deceptive or which is likely to create an erroneous impression regarding its character in any respect, including suggesting that the product is in fact another with which it might be confused, or in such a manner that may lead the consumer to suppose that the food is connected with any other such product.97 The Codex Food Labelling Standard sets out those aspects of information that must appear on all prepackaged foods. These include: (i) Food Name The Codex states the purpose of the food name is to indicate the true nature of the food. It should normally be specific and not generic. It may also be a Codex legal name, that is, one that has been established for a food in a Codex standard. In other cases the name prescribed by national legislation is to be used. In the absence of any such name, either a common or usual name must be used which exists by common usage as an appropriate descriptive term and which is neither misleading nor confusing to consumers. Brand names and trade marks may only be used if they accompany a Codex legal, national legal or customary name. The label should also contain, in close proximity to the name of the food, additional words or phrases as necessary to avoid misleading or confusing the consumer about the true nature and/or physical condition of the product, detailing, for example, any treatment the foodstuff has undergone, such as reconstitution, drying, concentrating or smoking.98 (ii) List of Ingredients A list of ingredients must appear on all prepackaged food, with the exception of single ingredient foods. The list is to be preceded by an appropriate title which includes the word ‘ingredient’. Ingredients are to be listed in descending order of weight at the time of manufacture of the food. Where an ingredient is the product of two or more ingredients, this may be declared in its compound form, provided that it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion. Where a compound ingredient, for which a name has been established in a Codex standard or in national legislation, constitutes less than five per cent of the food, the ingredients, other than food additives which serve a technological function in the finished product, need not be declared. Foods and ingredients which are known to cause hypersensitivity should always be declared. These include cereals containing gluten, eggs, fish, peanuts, soybeans and milk. The presence in any food or ingredient obtained through biotechnology of an allergen transferred from any of these foods must be declared. Where it is not possible to provide adequate information in this regard, the food containing the 96 97 98

Article 1 thereof. Article 3. Article 4.1.

(E) MacMaolin Ch4

9/2/07

15:16

Page 160

160 International Influences on EU Food Law allergen should not be marketed at all. Added water should also be declared in the list of ingredients, except where it forms part of another ingredient used in a compound food, such as broth or brine. Water that evaporates in the course of manufacture need not be declared. Where a food is to be reconstituted by the addition of water, the ingredients may be listed in order of their proportion in the reconstituted product, provided that this is made clear on the label. Class names are also set for groups of ingredients that may all be labelled under the same generic name. For example, all refined oils other than olive oil may simply be listed in the ingredients listing as ‘oil’, provided that this is preceded by the term ‘vegetable’ or ‘animal’ as appropriate, and further qualified by the term ‘hydrogenated’ or ‘partially hydrogenated’ where applicable. Similarly, refined fats may all be labelled ‘fat’ if preceded by the term ‘animal’ or ‘vegetable’ where appropriate, just as all types of cheese or a mixture of cheeses may be labelled ‘cheese’, provided that the labelling and presentation of the food does not refer to a specific type of cheese, and all ‘poultrymeat’ may simply be listed in the ingredients as such, provided that the labelling does not refer to a specific type of poultry. However, pork fat, lard and beef fat must always be clearly labelled as such. Class titles are also available for use in the ingredients listing for food additives. The class title, such as emulsifier, acidity regulator, colour, sweetener or flavour enhancer, is to be used together with the specific name or recognised numerical identification as required by national legislation. The expression ‘flavours’ may be qualified by terms such as ‘natural’ or ‘artificial’ as appropriate. Food additives that do not perform a technological function in the finished product are exempt from declaration in the list of ingredients.99 Where the labelling of a food places special emphasis on the presence of one or more valuable or characterising ingredients, or where the description of the food has the same effect, the ingoing percentage of the ingredient at the time of manufacture should be declared. Similarly, where the labelling of a food places special emphasis on the low content of one or more ingredients, the percentage of the ingredient in the final product should be declared. However, a reference in the name of a food to a particular ingredient will not of itself constitute the placing of special emphasis, and a reference in the labelling of a food to an ingredient used in a small quantity and only as a flavouring will not of itself constitute the placing of special emphasis.100 (iii) Net Contents The net contents are to be declared in the metric system (‘Système International d’Unités’ units). These net contents are to be declared for liquid foods by volume, for solid foods by weight, and for semi-solid or viscous foods by either weight or volume. Any food carried in a liquid medium, such as water, vinegar or fruit juice for fruit products, must state the drained net weight of the food.101 The name and 99 100 101

Article 4.2. Article 5.1. Article 4.3.

(E) MacMaolin Ch4

9/2/07

15:16

Page 161

4.3 FAO/WHO Codex Alimentarius 161 net contents of the food should appear in a prominent position and in the same field of vision.102 (iv) Other Details The name and address of the manufacturer, packer, distributor, importer, exporter or vendor should appear on the labelling.103 Similarly, the country of origin of the food should be declared where its omission would mislead or deceive the consumer. Where a food undergoes processing in a second country which changes its nature, the country in which this processing occurs is to be considered the country of origin for labelling purposes.104 Instructions for use, including reconstitution where applicable, should be included on the label as necessary to ensure the correct utilisation of the food.105 The lot number should also be marked.106 The date of minimum durability should be declared. This should consist at least of the day and the month for products with a minimum durability of not more than three months or the month and the year for products with a minimum durability of more than three months. The date should be declared as ‘best before . . .’ where the date is indicated and ‘best before end . . .’ in other cases. A date of minimum durability is not required for fresh fruits and vegetables; wines, liqueur wines, sparkling wines and aromatised wines; beverages containing more than 10 per cent by volume of alcohol; bakers’ wares which are normally consumed within 24 hours of their manufacture; vinegar; salt; solid sugars; confectionery products consisting of flavoured and/or coloured sugars; and chewing gum. In addition to the date of minimum durability, any special conditions for the storage of the food should be declared on the label if the validity of the date on the label depends on this.107 The label of a food which has been treated with ionising radiation should carry a written statement indicating this in close proximity to the name of the food. The use of the international food irradiation symbol is optional. When it is used, it too must appear in close proximity to the name of the food. When an irradiated product is used as an ingredient in another food, this is to be declared in the list of ingredients.108 Any information or pictorial device may be displayed on food labelling provided that it is not in conflict with the mandatory standards of the Codex labelling standard. If grade designations are used, they must be readily understandable and must not be misleading or deceptive in any way.109 All mandatory labelling must be clear, prominent, indelible and readily legible by the consumer. On language, all the Codex standard states is that if the language used on the original label is not acceptable to the consumer for whom it is intended, a 102 103 104 105 106 107 108 109

Article 8.1.4. Article 4.4. Article 4.5. Article 4.8. Article 4.6. Article 4.7. Article 5.2. Article 7.

(E) MacMaolin Ch4

9/2/07

15:16

Page 162

162 International Influences on EU Food Law supplementary label containing the mandatory information in the required language may be used instead of relabelling. The supplementary label should fully and accurately reflect the information given in the original label.110 Nutrition Labelling and Dietary Claims The Codex Guidelines on Nutrition Labelling are designed to ensure that consumers are provided with information that enables them to make an informed choice, based on accurate information. In particular, this must be done by conveying truthful details about the nutrients in food, encouraging the use of sound nutrition principles in the formulation of foods which benefit public health, and providing the opportunity to include supplementary nutrition information on the label. Nutrition labelling should not deliberately imply that a food which carries such labelling necessarily has any nutritional advantage over a food which is not so labelled. The Guidelines recommend procedures for the nutrition labelling of foods. Nutrition labelling consists of two components: nutrient declarations and supplementary nutrition information. A nutrient declaration is a standardised statement or listing of the nutrient content of a food.111 Nutrition claims are deemed to include any representation which states, suggests or implies that a food has particular nutritional properties including, but not limited to, its energy value and content of protein, fat and carbohydrates, as well as the content of vitamins and minerals.112 Nutrient declarations should be mandatory for foods in relation to which nutrition claims are made. Nutrient declarations should be voluntary for all other foods.113 Nutrition labelling should include information on energy values; protein, carbohydrate and fat levels; any other nutrients for which a nutrition claim is made, such as fibre; and any other nutrient considered to be relevant for maintaining a good nutritional status as required by national legislation. Vitamins and minerals may also be listed, but only when present in significant amounts (usually at least five per cent of the established recommended daily intake).114 Guidelines are also set in relation to how this information should be presented; for example, information on energy should be expressed in kJ and kcal per 100 g or per 100 ml or per package if the package contains a single portion or ‘carbohydrate . . .g, of which sugars . . .g’, where the total carbohydrate value and type of carbohydrate is declared.115 Supplementary nutrition information may also appear on the labelling. It should be optional and should only be given in addition to, and not in place of, the nutrient declaration, except in countries where the target population has a high 110 111 112 113 114 115

Article 8. Article 2.3. Article 2.4. Article 3.1. Article 3.2. Article 3.4.

(E) MacMaolin Ch4

9/2/07

15:16

Page 163

4.3 FAO/WHO Codex Alimentarius 163 illiteracy rate and/or comparatively little knowledge of nutritional values. In such situations, food group symbols or other pictorial or colour presentations may be used without the nutrient declaration. Supplementary nutrition information on labels should be accompanied by consumer education programmes to increase consumers’ understanding and use of the information.116 There are also separate Codex guidelines on the use of nutrition and health claims.117 Nutrition claims are defined as being: any representation which states, suggests or implies that a food has particular nutritional properties including but not limited to the energy value and to the content of protein, fat and carbohydrates, as well as the content of vitamins and minerals.118

Simply mentioning substances in the list of ingredients, nutrients as a mandatory part of nutrition labelling or quantitative or qualitative declarations of certain nutrients or ingredients on the label as required by national legislation are not nutrition claims.119 Several additional requirements relating to nutrition labelling are set out in the Guidelines. First, where a food is by its nature low in or free from the nutrient that is the subject of the claim, the term describing the level of the nutrient should not immediately precede the name of the food but the name of the nutrient should also appear, for example ‘a low-fat food’ or ‘a fat-free food’.120 This really just offers a clarification of how such products should be labelled rather than offering any sort of consumer protection provision. Second, comparative claims that compare the nutrient levels and/or energy values of two or more foods, such as ‘reduced sodium’, ‘fewer calories’ or ‘increased fibre’, are permitted, provided that the foods being compared are different versions of the same food or similar foods and the foods being compared are clearly identified. The amount of difference in the energy value or nutrient content should be stated. Any such claim should be based on a relative difference of at least 25 per cent in the energy value or nutrient content. Use of the word ‘light’ should follow the same criteria as for ‘reduced’ and should include an indication of the characteristics that make the food light.121 Claims relating to the function of a nutrient in the body are permitted by the Guidelines, subject to certain conditions. These pre-requirements include that only those essential nutrients for which a Nutrient Reference Value (NRV) has been established in the Codex Guidelines on Nutrition Labelling or those nutrients which are mentioned in officially recognised dietary guidelines of the national authority having jurisdiction, should be the subject of a nutrient function claim. In addition, the food in respect of which the claim is made should be a significant source of this nutrient in the diet. The nutrient function claim should 116

Article 4. Guidelines for Use of Nutrition and Health Claims, Codex Guidelines 23/1997, revised 2004. These guidelines originally dealt with nutrition claims only. Health claims were added to the guidelines in the 2004 revision. This is discussed in more detail in Chapter 6 below. 118 Article 2.1. 119 Ibid. 120 Article 5.2. 121 Article 6. 117

(E) MacMaolin Ch4

9/2/07

15:16

Page 164

164 International Influences on EU Food Law be based on scientific consensus. No such claim should ever imply or include any statement to the effect that the nutrient would afford a cure or treatment for or protection from disease.122 Claims that relate to dietary guidelines or ‘healthy diets’ are only permitted in set circumstances. For example, such claims may only be made where they relate to the pattern of eating contained in dietary guidelines officially recognised by the appropriate national authority. However, foods should not be described as ‘healthy’, or be represented in a manner that implies that it in and of itself will impart health. Foods may only be described as forming part of a ‘healthy diet’ where the label carries a statement relating the food to the pattern of eating described in recognised dietary guidelines.123 The Codex General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses also applies to all products that are directly offered to consumers or are supplied for catering purposes.124 Foods for special dietary uses are those specially processed or formulated to satisfy particular dietary requirements due to a particular physical or physiological condition and/or specific diseases and disorders, and which are presented as such, including foods for infants and young children. Foods coming within such a category must not be described or presented in a manner that is false, misleading or deceptive or that is likely to create an erroneous impression regarding their character in any respect,125 examples of such claims being set out in the Codex General Guidelines on Claims.126 Nothing in the labelling and advertising of foods to which this applies may imply that advice from a qualified person is not needed.127 The label of all prepackaged foods for special dietary uses should bear several specified pieces of information in addition to those items that must appear under the terms of the General Standard on labelling. In addition to the name of the food, the designation ‘special dietary’ or ‘special dietetic’ or an appropriate equivalent term may be used in conjunction with the name, the characterising essential feature to be stated in appropriate descriptive terms in close proximity to the name of the food. Nutrition labelling information must appear, including the amount of energy, protein, carbohydrate and fat per 100 g, 100 ml or portion as appropriate. However, information must also be given as to the total quantity of those specific nutrients or other components which provide the characterising essential feature for the special dietary use for which the food is intended per 100 g, 100 ml or portion. Finally, as one other alteration to the manner of labelling prescribed by the general Codex standard, storage instructions for opened packages of food for special dietary uses should be included on the label if necessary to ensure that the opened product maintains its wholesomeness and nutritive value. A warning 122

Article 7. Article 8. 124 Codex Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Use, Codex Standard 146/1985. 125 Article 3.1. 126 Codex Guidelines 1/1979. Revised 1991. 127 Article 3.2. 123

(E) MacMaolin Ch4

9/2/07

15:16

Page 165

4.3 FAO/WHO Codex Alimentarius 165 should be included on the label if the food is not capable of being stored after opening.128 All other aspects of the labelling of these products that are covered by the general labelling standard should be as stated in the general labelling standard. There are additional labelling requirements for foods covered by the special dietary standard that are not covered in any way by the general labelling standard. For example, a food that has not been modified but which is suitable for use in a particular dietary regimen because of its natural composition may not be designated as ‘special dietary’ or any other equivalent term. However, such food may bear a statement on the label that by its nature it possesses the essential distinguishing characteristic, provided that this statement does not mislead the consumer.129 The same exemptions from the terms of this standard apply as for the general labelling standard.130 The Codex Standard for the Labelling of and Claims for Foods for Special Medical Uses covers those foods which are for special dietary uses and which are specially processed or formulated or presented for the dietary management of patients only to be used under medical supervision.131 These foods are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb or metabolise ordinary foodstuffs or certain nutrients, or who have other special medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two.132 The formulation of any foods for special medical purposes should be based on sound medical and nutritional principles. Their use must be demonstrated by scientific evidence, to be safe and beneficial in meeting the nutritional requirements of the persons for whom they are intended. Any labels or advertising of these types of foods should always provide sufficient information as to the nature and purpose of the food, as well as detailed instructions and precautions for their use. The advertising of these products to the general public should be prohibited. Foods for special medical purposes should be labelled in accordance with the Codex General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses, except that some aspects, such as those relating to nutrition labelling, quantitative labelling and exemptions, do not apply to medical foods. They are replaced with specific requirements for these aspects of the medical food label. Additionally, a prominent statement ‘use under medical supervision’ should appear on the label in bold letters, separate from other information.133 There should also be a warning of the hazards that may result following consumption of the food by individuals who do not have the disease,

128 129 130 131 132 133

Article 4. Article 5. Article 6. Codex Standard 180/1991. Article 2. Article 4.4.

(E) MacMaolin Ch4

9/2/07

15:16

Page 166

166 International Influences on EU Food Law disorder or medical condition for which the product is intended.134 A complete statement concerning use of the food, adequate precautions and known side effects should also be included on the labelling.135 This information may be provided separately from the packaging. The Codex General Guidelines on Claims apply to all foods, irrespective of whether or not the food concerned is covered by an individual Codex standard.136 The principle upon which the Guidelines are based is that no food should be described or presented in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect. The person marketing the food should be able to justify the claims made. A claim is defined as being: any representation which states, suggests or implies that a food has particular characteristics relating to its origin, nutritional properties, nature, production, processing, composition or any other quality.137

Claims which it is suggested should be prohibited by the Guidelines include those stating that a food is an adequate source of all essential nutrients, except where these claims are allowable by a Codex standard or where appropriate authorities have accepted the product to be such a source; those implying that a balanced diet or ordinary foods cannot supply adequate amounts of all nutrients; claims that cannot be substantiated; those on the suitability of a food for use in the prevention, alleviation, treatment or cure of a disease, disorder, or particular physiological condition unless they are in accordance with the provisions of the Codex standards or guidelines for foods for special dietary uses or, in the absence of such a standard, they are permitted under the laws of the country in which the food is distributed; and claims that could give rise to doubt about the safety of similar food or which could arouse or exploit fear in the consumer.138 The Guidelines also set out examples of the types of claim that could be considered misleading. In particular, it states that meaningless claims include incomplete comparatives and superlatives and claims about good hygienic practice, such as ‘wholesome’ or ‘healthy’.139 Some claims are expressly permitted by the Guidelines. These include claims that a food has obtained an enhanced or special nutritive value by means of the addition of nutrients, such as vitamins, minerals and amino acids. However, such claims are only permissible where the addition has been made on the basis of nutritional considerations according to the Codex General Principles for the Addition of Essential Nutrients to Foods.140 Terms such as ‘natural’, ‘pure’, ‘home made’, ‘organically grown’ and ‘biologically grown’ may 134 135 136 137 138 139 140

Article 4.4.3. Article 4.5.2. Codex Guidelines 1/1979. Revised 1991. Article 2. Article 3. Article 4. Codex Guidelines 9/1987. Revised 1991.

(E) MacMaolin Ch4

9/2/07

15:16

Page 167

4.3 FAO/WHO Codex Alimentarius 167 only be made if they are used in accordance with national regulations. Claims about religious or ritual preparation, such as ‘halal’ and ‘kosher’, may only be made where the food conforms to the requirements of the relevant religious or ritual authorities. Claims that a food has special characteristics may be made even where all such foods have the same characteristics, provided that this fact is made clear on the label. Claims highlighting the absence or non-addition of particular substances to food may also be made, provided that such claims are not misleading. Finally, claims which highlight the absence or non-addition of one or more nutrients should be regarded as nutrition claims and should therefore be accompanied by nutrient declarations in accordance with the Codex Guidelines on Nutrition Labelling.141 Organic Production and Labelling Requirements The foreword to the Codex Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Goods defines its aim as the protection of consumers from deception and fraud in the marketplace and unsubstantiated product claims; to protect producers of organic produce from misrepresentation of other agricultural produce as being organic; to ensure that all stages of production, preparation, storage, transportation and marketing are subject to inspection and comply with the Codex Organic Guidelines; to harmonise provisions for the production, certification, identification and labelling of organically grown produce; to provide international guidelines for organic food control systems in order to facilitate recognition of national systems as equivalent for the purposes of import; and to maintain and enhance organic agricultural systems in each country so as to contribute to local and global preservation.142 The Guidelines recognise the importance of harmonising organic standards at international level. It is stated that these guidelines are to be considered a first step in global harmonisation of standards for organic food. As yet, there is limited experience in the development and implementation of such international requirements. Moreover, regional differences on organic production methods persist. The Guidelines were thus claimed to be merely useful in assisting countries to develop national regimes regulating the production, marketing and labelling of organic foods. It was recognised that they would need regular improvement and updating in order to take into account technical progress and experiences of implementation. The Guidelines are not in any way to prejudice the implementation of more restrictive arrangements. More detailed rules may therefore be introduced by member countries in order to maintain credibility amongst consumers and to prevent fraudulent practices. A product is regarded by the Guidelines as bearing indications referring to organic production methods where, in the labelling or claims, including 141 142

Article 5. Codex Guidelines 32/1999. Revised 2001 and 2004.

(E) MacMaolin Ch4

9/2/07

15:16

Page 168

168 International Influences on EU Food Law advertising material or commercial documents, the product, or its ingredients, is described using words such as ‘organic’, ‘biodynamic’, ‘ecological’, or words of similar intent which suggest to the purchaser that the product or its ingredients has been obtained by organic production methods.143 Materials and products produced from genetically modified organisms are deemed incompatible with the principles of organic food production and are not accepted under the guidelines.144 More specifically, genetically modified preparations of micro-organisms and enzymes used in food processing are not permitted as an ingredient of nonagricultural origin.145 Foods should only refer to organic production methods if they derive from an organic farm system employing management practices that seek to nurture ecosystems which achieve sustainable productivity and provide weed, pest and disease control through a diverse mix of mutually dependent life forms, recycling plant and animal residues, crop selection and rotation, water management, tillage and cultivation. Soil fertility, for example, should be maintained and enhanced by a system which optimises the biological activity and physical and mineral nature of the soil as the means to provide a balanced nutrient supply for plant and animal life as well as to conserve soil resources, while pest and disease management should be attained by means of encouraging a balanced host/predator relationship, augmentation of beneficial insect populations, biological and cultural control, and mechanical removal of pests and affected plant parts. Production should be sustainable, with the recycling of plant nutrients constituting an essential part of the fertilisation strategy. The basis for organic livestock husbandry should be the development of a harmonious relationship between land, plants and livestock, and respect for the physiological and behavioural needs of livestock. This must be achieved through a combination of providing good quality organically grown feedstuffs, appropriate stocking rates, livestock husbandry systems appropriate to behavioural needs, and animal management practices, that minimise stress and seek to promote animal health and welfare, prevent disease and avoid the use of chemical allopathic veterinary drugs, including antibiotics.146 Organic products should be labelled in accordance with the Codex General Standard for the Labelling of Prepackaged Foods.147 Any such labelling claims may refer to organic production methods only where the product has been produced in accordance with the Codex Organic Guidelines and has been subject to its inspection measures.148 In order to satisfy this requirement, all ingredients of agricultural origin must have been produced in accordance with these guidelines. However, by way of derogation, some ingredients of agricultural origin not 143

Article 1.1. Article 1.5. 145 Article 3 of the Guidelines does permit the addition of specified ingredients of non-agricultural origin to organic food. The positive list of such ingredients is set out in Annex 2, Table 3. 146 Article 2.1. 147 Codex Standard 1/1985. Revised 1991 and 2005. 148 Article 3.2. 144

(E) MacMaolin Ch4

9/2/07

15:16

Page 169

4.3 FAO/WHO Codex Alimentarius 169 satisfying these requirements may be used, up to a maximum level of five per cent of the total ingredients, excluding salt and water, in the final product and where these ingredients of agricultural origin are not available, or are not available in sufficient quantity, in their organic state. The product should not contain any ingredient of non-agricultural origin not permitted in Annex 2 to the Guidelines.149 No organic food, nor its ingredients, may be subjected to ionising treatment.150 Member countries may consider enabling organic production labelling to be used where the product contains a minimum of 70 per cent organic ingredients.151 The rules on the production and preparation of organic foods set out in the Codex Guidelines require that the production requirements of Annex 1 should be satisfied. Substances listed in Annex 2 may be used, provided that the corresponding use is not prohibited in general agriculture and/or food production. Conditions on the use of these substances may be set by organic certification bodies. Annex 1 sets out the principles of organic production. It states that for plants and plant products, soil fertility should be maintained or increased by either the cultivation of legumes, green manures or deep-rooting plants in an appropriate multi-annual rotation programme or the incorporation in the soil of organic material produced in accordance with the Guidelines. For example, by-products from livestock farming, such as farmyard manure, may be used if they come from livestock holdings producing in accordance with the Guidelines. Similarly pests, diseases and weeds should only be controlled by, inter alia, appropriate rotation programmes, protecting natural enemies of pests by providing favourable habitats such as hedges and nesting sites or the grazing of animals. Organic livestock management should aim to utilise natural breeding methods, minimise stress, prevent disease, progressively eliminate the use of allopathic veterinary drugs (including antibiotics), reduce the amount of animal feed containing products of animal origin, and maintain animal health and welfare. The use of chemical allopathic veterinary drugs or antibiotics for preventative treatments is prohibited. The transportation and slaughter of livestock should be managed in a calm and gentle way, avoiding or minimising stress and/or suffering. Herbivores must have access to organic pasture and all other animals to open air runs. The only exceptions to this are where indicated by the animals’ physiological state, inclement weather conditions or the state of the land. Livestock may not be transferred between organic and non-organic units. However, where livestock from a non-organic source is introduced to organic land, and products therefrom are to be sold as organic, such livestock must be reared according to the guidelines for set compliance periods. For example, cows used for meat production must have been reared on organic land for a minimum of 12 months and at least three-quarters of their life. In relation to poultry this must be for their entire life, but for eggs it is a minimum of six weeks. All poultry must be reared in open-range conditions and 149 150 151

Articles 3.3 and 3.4. Article 3.3.e. Article 3.6.

(E) MacMaolin Ch4

9/2/07

15:16

Page 170

170 International Influences on EU Food Law have free access to open-air runs whenever the weather permits. All mammals must have access to pasture or an open-air exercise area, which they must be able to use whenever conditions permit. All mammal housing must contain a comfortable, clean and dry rest area of sufficient size, with ample dry bedding strewn with litter material. All livestock systems should source animals’ diet from organic feed containing suitable amounts of roughage, cereals and milk as appropriate. They must also have ample access to fresh water. Inspection and certification systems may be used to verify the labelling of, and claims for, organically produced foods.152 Development of these systems is to take account of the Codex Principles for Food Import and Export Inspection and Certification.153 These inspection and certification systems should comprise at least the application of the measures and other precautions set out in Annex 3. For example, it must be ensured that organic production takes place in a unit where the land parcels, production areas, farm buildings and storage facilities for crops and livestock are clearly separate from those of any other unit which does not produce organically. Written and/or documentary accounts should be kept which enable inspection officials to trace the origin, nature and quantities of all raw materials used and of all agricultural products sold. Livestock should be identified individually, or for small mammals or poultry by herd or flock. Operators should maintain detailed records of breeding, disease management, treatments and medicines administered, feed provided and the source of the feedstuffs and transportation, slaughter and/or sales. There should be a full physical inspection of the production unit at least once a year. Foodstuff Specific Codex Alimentarius Standards The Codex Standard for Chocolate sets out the minimum quantity of cocoa solids for chocolate at 35 per cent.154 Milk chocolate must contain a minimum of 25 per cent cocoa solids and milk chocolate with high milk content a minimum of 20 per cent.155 All chocolate products must carry a declaration of the cocoa solids content in close proximity to the name.156 The Codex Standard for Composite and Filled Chocolate sets minimum standards for products described in the Chocolate Standard to which organoleptic property modifying ingredients have been added. This Codex Standard also applies to products consisting of chocolate with a distinct filling of something other than chocolate.157 The Codex Standard for Cocoa Butter,158 as an ingredient in the manufacture of chocolate and chocolate products defines this as the fat obtained from cocoa beans with a maximum of 1.75 per cent 152 153 154 155 156 157 158

Article 6. Codex Guideline 20/1995. Codex Standard 87/1981. Revised 2003. Article 3. Article 7.3.1. Codex Standard 142/1983. Codex Standard 86/1981. Revised 2001.

(E) MacMaolin Ch4

9/2/07

15:16

Page 171

4.3 FAO/WHO Codex Alimentarius 171 free fatty acid content and 0.7 per cent unsaponifiable matter.159 The Codex Standard for Cocoa Butter Confectionery covers the product obtained by an adequate process of manufacture from cocoa butter, milk solids and sugars.160 Cocoa butter must constitute a minimum of 20 per cent of such products, sugar accounting for no more than 55 per cent.161 These products are to be labelled ‘Cocoa Butter Confectionery’, or ‘White Chocolate’ where permitted by national law.162 Finally, there are also standards set by the Codex Standard for Cocoa Powders (Cocoas) and Dry Mixtures of Cocoa and Sugars, which legislates for these products where they are intended for direct consumption.163 These are the products obtained from cocoa cake transformed into powder.164

4.3.4 Relationship between the Codex Alimentarius and EU Food Law The work and individual standards of the Codex Alimentarius Commission impact upon EU food law in a variety of ways. Community legislation on the production and marketing of food has been consistently modelled on, and aligned with, Codex standards. The most explicit example of this can be seen in the devising of new rules on the use of nutrition and health claims. As discussed in more detail in Chapter 6 below, the proposal for a regulation on this makes it quite clear that as a result of the existence of Codex criteria for such claims, and the recognition therein that any such declarations would now require proper scientific validation and qualification prior to use, it is now necessary to devise Community rules in alignment with these international standards. This is generally a two-way process, with many Codex standards also taking their initiative from harmonised Community legislation. The case law of the Court of Justice makes specific reference to Codex Alimentarius standards when determining whether the national laws of Member States on the naming and labelling of food are necessary and/or proportionate to the aim pursued. In particular, the Court will look at the international guidelines when assessing whether there is any ‘substantial difference’ between the composition of the product that a Member State seeks to prohibit from being marketed using a particular food name and products generally known by that name. Codex standards can be very persuasive in such Court determinations. For example, in Smanor the Court looked at the Codex standard for yoghurt in order to identify the key constituents of that food type.165 If the product that was prohibited by the national authorities in this case from using the generic name ‘yoghurt’ was found to differ significantly on 159

Article 2.1. Codex Standard 147/1985. 161 Article 3.1. 162 Article 7.1. 163 Codex Standard 105/1981. Revised 2001. 164 Article 2.1. 165 Case 298/1987, Proceedings for compulsory reconstruction against Smanor SA [1988] ECR 4489, para 22. 160

(E) MacMaolin Ch4

9/2/07

15:16

Page 172

172 International Influences on EU Food Law this key constituent from that which was set out in the Codex standard,166 then this could be key to enabling the Member State to demonstrate that there was in fact a ‘significant difference’ between the products, potentially enabling it to deviate from its Article 28 EC obligations in the name of consumer protection—a defence so rarely available to the Member States in such circumstances. It was contended in Deserbais that consumer protection and fair trading require that international agreements concerning the use of the name of a particular product be observed. Consequently each Member State could make the right to use a name such as ‘edam’ subject to compliance with the requirements laid down by the Stresa Convention and the Codex Alimentarius, both of which lay down a minimum fat content of 40 per cent for that type of cheese. The Court, however, found here that the Codex Alimentarius rules are in fact intended to provide guidance on defining the characteristics of foodstuffs. The mere fact that a product does not wholly conform to the standard laid down should not be sufficient in itself to justify a Member State from prohibiting its sale there.167 The Stresa Convention was not seen to be relevant here either as it was signed prior to the Treaty of Rome and only four Member States were party to it at the time. It was thus found that, provided that the rights of third countries are not involved, a Member State cannot rely on the provisions of a pre-existing convention like Stresa in order to justify restrictions on the marketing of products lawfully produced and marketed in another Member State. Finally, the important role of Codex Alimentarius standards in international trade regulation should also be noted here. If the WTO Agreements make specific reference to the Codex, and these same WTO rules can influence the shape and direction of EU food legislation, then this recognition at international level can also therefore indirectly affect EU food law. It must, where appropriate, comply with Codex standards in order to ensure, as far as possible, that related EU standards conform to the Community’s international obligations. In addition, other WTO members and regional trading blocs, such as NAFTA, recognise the international standards set out in the Codex. Adherence to the principles and requirements set out therein therefore assists in facilitating trade in food between the EU and these other countries. 4.4 CONCLUSION

While both the terms of the WTO Agreements and the Codex Alimentarius standards have an effect on EU food law, these are persuasive, not determinative. The 166

Now, Codex Standard for Fermented Milks, Codex Standard 243/2003. Codex Standard for Fermented Milks, Codex Standard 243/2003, para 15. The Stresa Convention was not seen to be relevant here either as it was signed prior to the Treaty of Rome. Only four Member States were party to it at the time. It was thus found that, provided that the rights of third countries were not involved, a Member State could not rely on the provisions of a pre-existing convention like Stresa in order to justify restrictions on the marketing of products coming from another Member State where they were lawfully produced and marketed. 167

(E) MacMaolin Ch4

9/2/07

15:16

Page 173

4.4 Conclusion 173 primary way of demonstrating compliance with WTO rules is to conform to other recognised international standards, such as those of the Codex. The EU has traditionally based much of its food legislation and case law decision-making on these standards in any case. Even where EU standards were adopted prior to the introduction of similar Codex standards, these tended to follow the Community’s rules. They are always at least, in both situations, of persuasive authority. This minimises the potential for international trade disputes over the content of EU food law. While there have been instances where the EU has been accused of breaching its obligations in this regard, most notably in relation to genetically modified organisms and protected geographical food names, so long as the EU continues to base much of its food law on existing international standards and practices, and enables those from third countries to access its authorisation procedures where applicable, global trading rules will have little impact upon EU food law.

(E) MacMaolin Ch4

9/2/07

15:16

Page 174

(F) MacMaolin Ch5

9/2/07

15:16

Page 175

5 Food Safety in the EU 5.1 INTRODUCTION

S

INCE THE 1990s there has been a succession of highly publicised scares about potentially lethal contaminations of food, such as avian flu in chickens, salmonella in eggs, mad cow disease in beef and dioxins in many foodstuffs. As a result, the institutions of the European Union have been forced to take action on the issue of food safety, and indeed to introduce legislative measures designed to convince the media, consumers and the electorate that they have moved to successfully solve them. This was the political effect of media scares. But the approaches that were taken did not take into account the clear distinction which this work highlights: that between the gravity of the effects of the occasional food contamination episode on the one hand, and the consequences of the obesity pandemic, attributable to the chronically bad diet of so many citizens. Avian flu, salmonella, mad cow disease and dioxins combined have never killed as many people in a year as die daily within the EU from obesity and its sequelae. The EU legislated for ‘scares’ affecting some, ignoring the approaching health pandemic that would affect many more. It is primarily due to the level of negative publicity that tends to surround these food safety concerns that the EU institutions have now devised a detailed set of rules designed to ensure that food produced within the Union is safe to eat. This has led ultimately to the establishment of a unique type of bureaucratic administrative body, the European Food Safety Authority (EFSA), which now assists in the development of EU food safety law and policy.1 5.2 DEVISING A NEW FOOD SAFETY POLICY FOR THE EU: THE BSE CRISIS

Much of the current food safety policy of the European Union has evolved directly from the crisis that arose out of Bovine Spongiform Encephalopathy (BSE) infections in cattle, particularly in the United Kingdom, of the late 20th century. Individual cattle were probably first infected by BSE in the UK as early as the 1970s.2 The Pathology Department of the Central Veterinary Laboratory (CVL) of 1 See also Chapter 4 of M Lee, EU Environmental Law: Challenges, Change and Decision-making (Oxford, Hart Publishing, 2005). 2 ‘The BSE Inquiry: The Report’, ISBN 0105569860. See also K Vincent, ‘Mad Cows and Eurocrats—Community Responses to the BSE Crisis’ (2004) 10 European Law Journal 499.

(F) MacMaolin Ch5

9/2/07

15:16

Page 176

176 Food Safety in the EU the UK State Veterinary Service (SVS) first investigated the death of a cow in September 1985, but the nature of the disease that had caused its death was masked by other factors and was thus not registered at the time. A question remains as to why it took so long for the true picture to emerge. The Pathology Department considered two further cases of BSE at the end of 1986 and identified these as being likely to be a Transmissible Spongiform Encephalopathy (TSE) in cattle. By the end of 1987 it had been concluded that the cause of the reported cases of BSE was the consumption of meat and bone meal which was made from animal carcasses and incorporated into animal feed. An inquiry into the BSE crisis was announced in the UK Parliament on 22 December 1997, and set up on 12 January 1998. Its function was to establish and review the history of the emergence and identification of BSE and actions taken in response to it. The BSE Inquiry found that the disease probably originated from a novel source early in the 1970s, possibly in a cow or other animal that developed the disease as a consequence of a gene mutation, but that the true origin of the disease will probably never be known with full certainty. One of the main difficulties with a disease like BSE is that it has a very long incubation period. This makes it difficult to immediately assess whether it is transmissible to humans. Initially, it was thought that the risk of transmission of BSE to humans was remote and that ‘it was most unlikely that BSE would have any implications for human health’.3 This assessment of risk was made on the basis that BSE was probably derived from scrapie and could thus be expected to behave like scrapie. Scrapie had not been transmitted to humans in over 200 years and so BSE was not likely to be transmitted in this manner either. This report continued to be cited in the following years as constituting a scientific appraisal that the risks posed by BSE to humans were remote and that no precautionary measures were needed other than those recommended by this Southwood Working Party. The BSE Inquiry found that despite increasing knowledge over the years, the public was not informed of any change in the perceived likelihood that BSE might be transmissible to humans. They were repeatedly reassured that it was safe to eat beef. Yet again, one might reasonably ask why this happened. By the end of 1989, 10,091 cases of BSE had been confirmed in the UK. On 1 March 1990 the EU restricted exports of live cattle to those aged under six months. On 10 May 1990 it was announced that a siamese cat had died of spongiform encephalopathy, resulting in a rash of media comment, speculating that the cat had caught BSE and that humans might be next. Exporting animal feed containing Specified Bovine Offal (SBO—those tissues in cattle considered most likely to be infective) to other EU Member States was prohibited. Its use as such was also banned in the UK, as little as one gram of infective material being enough to infect cattle to which it has been fed. Some education authorities began to ban beef altogether from school meals. On 8 June 1990 the EU Council of Ministers agreed that 3 Report of the working party on Bovine Spongiform Encephalopathy (Southwood Report) (London, Department of Health/MAFF, 1989).

(F) MacMaolin Ch5

9/2/07

15:16

Page 177

5.2 The BSE Crisis 177 bone-in beef exported from the UK could only come from holdings where BSE had not been confirmed in the previous two years. By the end of 1990 the number of confirmed cases of BSE in cattle had risen to 24,396. An Expert Group on Animal Feedingstuffs was established by the UK Ministry for Agriculture (then MAFF) on 6 February 1991. It reported on 15 June 1992 that the steps taken to date to prevent BSE being transmitted to animals in feed were satisfactory and adequate. In particular, the Group considered whether the practice of feeding animal protein to animals should be discontinued. It decided that there was no scientific justification for such a step. Figures later demonstrated that the feed ban had resulted in a steady year-on-year reduction in the number of new infections. However, on 27 July 1994 the European Commission decided that existing restrictions on the export of UK beef should be replaced with two new measures. One was a ban on the export of beef-in bone except from cattle which had not been on holdings where BSE had been confirmed in the previous six years. The other measure affected beef from cattle which had been on such a holding within that time. This could not be exported unless it was deboned with adherent tissues removed. In December 1994 the Commission amended this decision to exempt from these measures beef from cattle born after 1 January 1992. Subsequently in July 1995 this exemption was replaced with one that exempted beef from cattle less than 30 months of age at slaughter. These decisions will be examined in more detail later in this chapter. During 1995 a number of events served to increase public anxiety that it might be possible to contract CJD as a consequence of eating beef. Cases of CJD were reported in farmers whose herds had had BSE, and in several young people, which raised particular alarm because up until then the disease had almost invariably affected older victims. The safety of beef offal was questioned by scientists. In March 1996 it was announced in the UK Parliament by the Secretary of State for Health that 10 people had contracted a new variant of the invariably fatal Creutzfeldt-Jakob disease (vCJD), and that it was probable that they had caught BSE. By September 2000 over 80 cases had been reported. This outbreak of BSE, and its transmission to humans, had been almost exclusively a United Kingdom disaster. Only four other vCJD victims had been diagnosed elsewhere in the EU by the time of the publication of the BSE inquiry report in October 2000, two confirmed and one probable case in France and one confirmed case in Ireland. Over 170,000 cattle had been diagnosed with BSE in the UK at that stage, compared with fewer than 1,500 elsewhere. One of the key problems with controlling the spread of an infection like BSE that has its source in beef cattle, is that merely not eating beef may not offer sufficient protection to the consumer. Products derived from beef enter the food chain in a variety of ways. Tallow, the fat that is extracted by the rendering process, and gelatine, derived from the skin and bone of cattle, are used in a wide variety of foodstuffs. Bovine fluids and tissues are also used in medicinal and cosmetic products. Another difficulty, identified by the Inquiry, was that the existing primary legislation, which was all that UK government departments could work with when

(F) MacMaolin Ch5

9/2/07

15:16

Page 178

178 Food Safety in the EU the outbreak of BSE became apparent, was not ideally suited to addressing the problems of BSE, in particular because the statutory powers relied upon to adopt measures had been enacted to deal with known hazards. It was several more years before it became established that there was a known hazard to human health and the extent of the risk that was posed. New secondary legislation could, it was noted, be introduced—but this required clearance, consultation and time under existing legislative processes. Pursuing a policy of deregulation, enforcing rules with a light touch, had also contributed to the magnitude of the outbreak. The UK BSE Inquiry found that a number of lessons could be learned from the outbreak and subsequent response to a disease like this. The fact that the origin of the epidemic remained unknown did, however, make it difficult to answer many other questions raised. In particular, it was found that an effective system of animal disease surveillance is a prerequisite to the effective control of such diseases. Also, where animal or public health is at stake, resort should be had to the best sources of scientific advice, wherever it is to be found, without delay. Where precautionary measures are introduced, such as the ban on ruminant feed, rigorous thought must be given to every aspect of its operation with a view to ensuring that it is watertight and is properly implemented and enforced. Reliance on a trade association or other similar bodies to communicate the importance of a precautionary measure is not, it was stated, always appropriate. Much was also offered on the use of advisory committees in such situations, such as ensuring that the reasoning behind any advice given is provided, that the nature and extent of any uncertainty should be clearly identified and that the advice of committees should normally be made public. In particular, it was noted that during the BSE crisis much advice and the communication of potential risks tended to be played down in order to avoid provoking any irrational public scare. The BSE Inquiry highlighted the possibility that in circumstances such as those at issue in this crisis, Member States may be constrained in terms of the protective measures they can take if the Community has already introduced legislation specifying what action may be taken in such circumstances. Specifically, it was noted that once definitive measures for a relevant outbreak of disease had been adopted by the European Commission, individual Member States were no longer entitled to adopt unilateral measures to deal with the risks posed by the disease. Take the Specified Bovine Offal (Amendment) Order 1995, for example.4 This order was introduced to amend the Specified Bovine Offal Order 1995,5 creating a new series of restrictions on the use of the vertebral column of bovine animals, and a new registration requirement for premises where meat is recovered by mechanical means. It also extended the restriction on exports from Britain to other Member States to include mechanically recovered beef intended for human consumption. The original order had been introduced to give effect to Decision 1994/474, which had

4 5

UK Statutory Instrument No 3246/1995. UK Statutory Instrument No 1928/1995.

(F) MacMaolin Ch5

9/2/07

15:16

Page 179

5.2 The BSE Crisis 179 established protection measures to counter the spread, and effects, of BSE.6 This decision prohibited the export from the UK to other Member States of all live cattle over six months old, as well as those of any age which were the offspring of cows in which BSE was either suspected or confirmed.7 The export of fresh beef on the bone was only permitted where it came from cattle from holdings on which no case of BSE had been confirmed in the previous six years.8 In addition to this, measures were introduced limiting the sale of offal, such as brain, spinal cord, spleen, tonsils and intestines to that taken from cattle aged less than six months at slaughter. The fact that measures being adopted at EU level may remove the power from Member States to adopt their own measures to deal with a crisis such as this could render the Specified Bovine Offal (Amendment) Order 1995 unlawful. This means that where a Member State has acted in a prompt manner in order to deal with the problem as soon as possible after it is identified, the measure enacted is open to challenge as being incompatible with Community law. This will continue to be the case until the Community itself has acted, and even then only if it adopts the same safety measures as the Member State.

5.2.1 Impact of Food Crises on EU Food Law and Policy: White Paper on Food Safety The Commission White Paper on Food Safety, which was published in 2000, was an attempt to clarify and direct future Community policy on the safe production and distribution of food.9 Its initiation was prompted to a large extent by the preceding BSE crises. The key initiative to come out of the White Paper has been the establishment of EFSA (although it was originally named more simply in the White Paper as the European Food Authority). Other issues dealt with in the 52-page document include controls over, and new methods of, devising food safety legislation, more general food safety controls, aspects of regulation relating to, inter alia, animal feed, animal health and welfare, food hygiene, contaminants and residues, packaging and irradiation, the provision of consumer information, and defining the role to be played by the European Commission in international food safety negotiations and developments. The White Paper commences by setting out, in very general terms, the European Union’s policy on food safety. It states that it must be built around high food safety standards that serve to protect and promote the health of the consumer. The importance of food law and policy is noted in the Paper’s recognition 6 Commission Decision 1994/474/EC of 27 July 1994 concerning certain protection measures relating to bovine spongiform encephalopathy and repealing Decisions 1989/469/EEC and 1990/200/EEC. [1994] OJ L 194/96. 7 Article 1(1) of Decision 1994/474. 8 Article 4(1) of Decision 1994/474. 9 Commission White Paper on Food Safety. COM (1999) 719.

(F) MacMaolin Ch5

9/2/07

15:16

Page 180

180 Food Safety in the EU that the production and consumption of food is central to any society and has economic, social and, in many cases, environmental consequences for all. Although health protection must, it is claimed, always take priority, these other issues should also be taken into account in the development of food policy. Environmental policy is, given that the state and quality of the environment may affect different stages of the food chain, to play an important role in ensuring safe food for the consumer. According to the White Paper, consumers should be offered a wide range of high quality, safe products coming from all Member States. This is recognised as being the essential role of the internal market. Every link in the food production chain must be as strong as the others if the health of consumers is to be adequately protected. This principle is to apply to food produced both within and outside the EU. It is stated that any food safety policy requires the assessment and monitoring of the risks to consumer health associated with raw materials, farming practices and food processing activities, requiring effective regulatory action to manage this risk, and it requires the establishment and operation of control systems to monitor and enforce the operation of these regulations. The White Paper also summarises the position of the Community in the devising and enforcement of food safety policy and law by stating that there must be a comprehensive and integrated approach to food safety, demanding that all aspects of food safety are addressed at European Union level, and European Union legislation is applied in an efficient way in all Member States in line with the principle of subsidiarity, but that enforcement should above all remain a primarily national, regional and local responsibility, each Member State having a duty towards not only its own citizens but all Union citizens and those of third countries as well. The White Paper recognises that food safety needs to be organised in a more coordinated and integrated way to deliver a high level of public health and consumer protection in accordance with the requirements of the EC Treaty, requiring the full collaboration and co-operation of all parties. Public confidence needs to be reestablished, as do food science, food controls and food law. One method of achieving this is through modernising existing EU food legislation to make it more coherent, understandable and flexible, and to promote better enforcement of that legislation, providing better transparency for consumers, as was recommended by the conclusions of the Helsinki European Council in December 1999. The Commission outlined its determination to improve controls over the safety of food by prioritising the actions set out in the White Paper, imposing upon itself a three year timetable for the taking of appropriate action. Those proposals considered to be the most important were to be put forward by the Commission by the end of 2000, allowing for the creation of a coherent and up-to-date body of food law, to be supported by the envisaged European Food Safety Authority, by the end of 2002. The guiding principle underlying the White Paper is that food safety policy is to be based on a comprehensive and integrated approach. This means that throughout the food chain, at all stages of the production process, there is to be adherence

(F) MacMaolin Ch5

9/2/07

15:16

Page 181

5.2 The BSE Crisis 181 to what are described as ‘the pillars of food safety’, namely scientific advice, data collection and analysis, regulatory and control aspects and consumer information. The role of all stakeholders in the food chain, from feed manufacturers and farmers through to consumers, are to be clearly defined to ensure the systematic and consistent implementation of food safety policy. Traceability of feed and food and their ingredients, transparency in food policy, a structured risk analysis process, use of the precautionary principle, environmental considerations, animal welfare, sustainability, quality and clear communication of production and processing information are all deemed to be essential to ensuring that Community food safety policy achieves the desired aims. Regulatory Aspects of the White Paper The White Paper recognised that the Community had created a broad body of legislation, covering aspects of primary production of agricultural products and the industrial production of processed food. The legislation, which had evolved over the past 30 years, was seen to be based on a blend of scientific, societal, political and economic forces, in particular within the context of creating the internal market. It was also recognised, however, that no overall coherence had guided this development, resulting in the need to develop and devise the Green Paper on the general principles of food law in the European Union, which identified the need for a major review of European food legislation.10 The principal problem was recognised as being attributable, not to a lack of legal instruments, but to the broad disparity in the means available to respond to situations in specific sectors, or the multiplicity of actions which need to be triggered in situations where a problem involves more than one sector of the broad regulatory framework. A new legal framework was thus proposed. Central to the devising of any such replacing framework is the creation of a coherent and transparent set of food safety rules. This would be initiated in the first instance by the Commission making a series of proposals laying down the principles that would ensure a coherent approach and fixing the principles, obligations and definitions applicable to this field, following the lines established by the Commission Green Paper and subsequent consultation on its content. Any new legislation would only be introduced following a detailed consultation process with interested parties, and its content would have to be clear, understandable and simple for all operators to put into effect. The proper implementation of such legislation would be ensured by close co-operation with the competent authorities at the appropriate levels in the Member States to ensure proper and consistent compliance and enforcement. The future proposals were also set the task of providing a general framework for those areas of food law not covered by harmonised rules but where the functioning of the internal market is to be ensured by mutual recognition, as developed by the Community Courts in their Cassis jurisprudence. As a 10

Green Paper on the general principles of food law in the European Union. COM (1997) 176 final.

(F) MacMaolin Ch5

9/2/07

15:16

Page 182

182 Food Safety in the EU consequence, Member States would only be allowed to restrict the marketing on their territory of products lawfully marketed in another Member State where this could be justified by a legitimate interest, such as the protection of public health, and where any such measures taken adhered to the principle of proportionality. There was to be a ‘stable to table’ or ‘farm to fork’ approach taken, with regulatory control exercised at all stages of production. The White Paper therefore proposed the establishment of a new legal framework for the production and use of animal feed. It was recognised that, although legislation cannot cover all potential incidents affecting the food and feed chain, it can set up appropriate requirements and controls enabling problems to be detected early and fast corrective action to be taken. Specifically, the materials that may be used in animal feed production, including animal by-products, thus need to be clearly defined. The creation of a positive list of those substances that may be used was seen to be desirable, but it was also thought that devising such a list would be a complex and time-consuming task. However, there would be scope for expanding the negative list of those substances that may not be used in food production. It was stated in the White Paper that the Commission was committed to producing a positive list in the medium term. Legislation would be proposed to exclude fallen animals or cadavers and condemned material from the food chain. Then, the only material allowed to be used in animal feed would be that deemed fit for human consumption. The Commission was also committed to pursuing the prohibition or phasing-out of antibiotics used as growth promoters in animal feed depending on their potential use in human and veterinary medicine as part of the broader strategy designed to control and contain antibiotic resistance. Overall, the feed manufacturing industry was to become subject to the same rigorous requirements and controls as the food producing sector. In order to achieve this, legislation would be introduced to ensure that feed producing plants obtain official approval and be subject to official controls at national and Community levels. A rapid alert system, similar to that proposed for the food sector, would be integrated into the feed sector. Animal Health and Welfare The White Paper did make proposals specifically designed to promote the health and welfare of animals, but only insofar as this concerned food safety. It was recognised that most of the legislation relating to animal disease, in particular Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathies (TSE), has been in the form of safeguard measures taken on an ad hoc basis. The adoption of these measures did not, by definition, involve all the Community institutions, nor do such measures provide for a fully consistent approach. The White Paper claimed that the Commission has addressed this problem by putting forward to the Parliament and the Council a comprehensive proposal based on Article 152 EC covering all measures to control BSE and TSE. Ad hoc emergency measures would continue to be used in the interim. The main measures proposed included surveillance and testing of risk categories, updating

(F) MacMaolin Ch5

9/2/07

15:16

Page 183

5.2 The BSE Crisis 183 feed bans and, most importantly, embargoes put in place in light of scientific advice. Little else about animal welfare is stated in the White Paper. What there is, centres on the need for such issues to be integrated more fully with regard to food policy—in particular, the impact on the quality and safety of products of animal origin intended for human consumption need to be reflected in legislation. Emergency Measures The Commission recognised in the White Paper that there were insufficient safeguard measures in place to facilitate an adequate response to identified risks to consumer health. It was noted that no legal instrument existed that would enable the Commission to adopt a safeguard measure on its own initiative, either for feed or for a processed food of non-animal origin originating from one of the Member States. It was thus proposed that a single emergency measure procedure applicable to all types of food and feed, whatever the geographical origin, be introduced to remove any existing disparities and close remaining loopholes. A comprehensive legislative proposal would be required to fulfil this aspiration. In addition to this, the White Paper recognised the need to simplify the decision-making process in order to ensure better efficacy and transparency and to speed up response times. Community food legislation can be introduced by one of several available Treaty procedures: Article 95 EC in the case of measures for the completion or the functioning of the internal market; Article 152 EC for measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health; Article 153 EC relating to consumer protection; and Article 37 EC relating to, predominantly, agriculture. Measures are adopted, depending on the applicable legal basis, either by the Council in co-decision with the Parliament following a proposal from the Commission (Article 251 EC) or after consultation of the Parliament following a proposal by the Commission.11 Article 202 EC provides that in the instruments that it adopts, the Council shall confer on the Commission powers for the implementation of the rules which the Council lays down, save in specific cases where it may reserve the right to exercise directly implementing powers itself. This transfer of competence would normally allow the Commission to rapidly transform the scientific advice that it receives by amending the appropriate legislation or adopting appropriate decisions. In some cases, however, in particular with food additives, implementing powers have not yet been conferred on the Commission. Hence, updating lists of positive substances can take several years from receipt by the Commission of scientific advice. Where such powers have been conferred on the Commission, for example in relation to flavourings, contaminants, pesticide residues, materials in contact with food, diet foods, irradiated foods or quick-frozen foods, the decision-making 11 For further discussion see A Dashwood, ‘Community Legislative Procedures in the Era of the Treaty on European Union’ (1994) 19 European Law Review 343; for further discussion see D Chalmers, C Hadjiemmanuil, G Monti and A Tomkins, European Union Law (Cambridge, CUP, 2006), pp 149–55.

(F) MacMaolin Ch5

9/2/07

15:16

Page 184

184 Food Safety in the EU process for transforming scientific advice into legislation or decisions was deemed unsatisfactory because the procedures in place were cumbersome and disparate, involved the use of different committees and different modalities, and were inhibited by a shortage of resources. As a consequence, it was recognised in the White Paper that all the procedures for the adoption and implementation of Community food legislation and its adaptation to technical and scientific progress required review. In particular, calls were made for the streamlining and reduction in the number of committees dealing with delegated legislation and the adoption of individual decisions, any new procedures to be in conformity with the Decision on comitology,12 involving better co-ordination to ensure that food safety issues are addressed as a continuum from ‘farm to fork’ through the application of a single regulatory procedure for the adoption of individual decisions, and an emergency procedure for all urgent matters of food safety.13 This could be better achieved, according to the White Paper, if clear and strict deadlines were fixed for the Commission to prepare an amendment or decision, for the Standing Committee to reach an opinion and for the Commission to finalise an amendment or decision, coupled with greater transparency at all stages of the regulatory process, supported by information and communication technologies which should be used extensively to automate the production and tracking of amendments and decisions and to accelerate their circulation between all the parties involved. Controls over the Operation of EU Legislation Responsibility for safe food production is shared among operators, who must ensure that they comply with legislative provisions and minimise risk on their own initiative; national authorities, who must oversee compliance with food safety standards by establishing control systems to ensure that Community rules are respected and enforced; and the European Commission, which, through the Food and Veterinary Office (FVO), carries out a programme of audits and inspections. The White Paper stated that the preceding food safety crises highlighted deficiencies in national systems of control, primarily due to a lack of harmonised Community approach to the design and development of national control systems. As a consequence, it was recognised that there was a clear need for a Community framework of national control systems to raise food safety standards across the European Union, with the operation of these systems to remain a national responsibility. This proposed framework would have three core elements, including the devising of operational criteria at Community level which national authorities would be expected to meet, forming the key reference points against which the competent authorities would be audited by the FVO; the development of 12 Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. [1999] OJ L 184/23. For further discussion see Chalmers et al, ibid, pp 159–67. 13 Several names are used for this approach to food regulation, including ‘farm to table’, ‘stable to table’, ‘farm to fork’ and ‘seed to silo’.

(F) MacMaolin Ch5

9/2/07

15:16

Page 185

5.2 The BSE Crisis 185 Community control guidelines promoting coherent national strategies and identifying risk-based priorities and the most effective control procedures; and enhanced administrative co-operation in the development and operation of control systems involving a reinforced Community dimension to the exchange of best practice between national authorities, promoting mutual assistance between the Member States by integrating and completing the existing legal framework. The White Paper on Food Safety clearly outlines the direction that EU food law should take in the future. A number of initiatives have been developed at Community level in its aftermath to achieve the aims set out therein. The Paper claims from the outset that the protection of human health must always take priority. While there is clearly a health protection element in much of the new legislation, the manner in which Community law on free movement has developed means that this remains the primary priority of the corpus of EU food laws. The White Paper calls for better enforcement of EU food law. This has since been the focus of a clear and consolidated regulation on verifying compliance with food law and animal welfare rules.14 It was also proposed that EU legislation should be made clearer, more coherent and more flexible, leading to better transparency for consumers. This has led to public consultations on how food labelling can be improved.15 It has also resulted in the introduction of new legislation, such as that on nutrition and health claims.16 However, as will be discussed in Chapter 6 below, lobbying during the legislative process has significantly reduced the potential for positive impact that this legislation could have had on health promotion. Finally, the increased role for scientists in the introduction of food laws has seen two major developments to the manner in which such rules are now devised. First, the scientific committee structure has been streamlined, leading to the establishment of the Standing Committee on the Food Chain and Animal Health.17 Second, it has led to the establishment of EFSA, which now plays a central role in assessing risks attached to the production and marketing of food.

5.2.2 The European Food Safety Authority The White Paper envisaged that a European Food Safety Authority would be central to the devising and implementation of EU food safety policy. This is now operational. The Paper states that the Authority is to be independent and is to have 14 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. [2004] OJ L 165/1. 15 DG SANCO Consultative Document on ‘Labelling: Competitiveness, Consumer Information and Better Regulation for the EU’, February 2006. 16 Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods. COM (2003) 424. 17 Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety. [2002] OJ L 31/1.

(F) MacMaolin Ch5

9/2/07

15:16

Page 186

186 Food Safety in the EU particular responsibility for two key areas underpinning more general Community food safety policy: risk assessment and communication on food safety issues. These are two of the three components of risk analysis. The other component—risk management—is thus to remain outside the remit of the Authority, leaving this task to the politicians and bureaucrats in the Parliament, Council and Commission. It was claimed in the White Paper that the inclusion of risk management in the mandate of the Authority would raise three concerns. First, the transfer of regulatory powers to an independent Authority could lead to a dilution of democratic accountability. Second, control must remain central to the Commission’s risk management process to enable it to act most effectively on the consumer’s behalf, most notably in providing that recommendations for action are implemented. This is to ensure that this institution remains in control of the responsibilities with which it is charged under the Treaties. Third, an authority with regulatory power could not be created under the existing institutional arrangements. To do so would require modification of the EC Treaty. So, what would be the advantage of a European Food Safety Authority were its role limited to that already undertaken by the existing individual scientific committees and the Commission? The White Paper claimed that the responsibilities of the Authority in preparing and providing scientific advice, collecting and analysing information to facilitate decision-making at institutional level, and the monitoring and surveillance of developments relating to food safety would all add a new dimension to already existing centralised processes and procedures, that it was hoped would assist in eliminating, or at least reducing, the risk of another crisis of BSE’s magnitude. In order to achieve this, the Authority was to be based on ‘the highest levels of independence, of scientific excellence and of transparency in its operations’ and it ‘should be in a position rapidly to establish itself as the authoritative point of reference for consumers, the food industry, Member State authorities and on the wider world stage’.18 It was also set the ambitious aspiration of being: ideally placed to develop the flexible, rapid, response that the new challenges require [providing] a single, highly visible, point of contact for all concerned [acting] not only as a point of scientific excellence, but also [to] be available to consumers to provide advice and guidance on important food safety developments [undertaking] information actions with a view to ensuring that consumers can make informed choices, and are better informed on food safety issues.19

In order to achieve this, it was envisaged in the White Paper that the Authority would work in close co-operation with national scientific agencies and institutions in charge of food safety, creating a network of scientific contacts throughout Europe and elsewhere, with the Authority at its centre. The Community institutions, in particular the Commission, must support the Authority, ensuring that it 18 19

White Paper on Food Safety, section 35. Ibid, section 36.

(F) MacMaolin Ch5

9/2/07

15:16

Page 187

5.2 The BSE Crisis 187 is properly resourced and staffed and, perhaps most importantly, taking full account of the opinions generated by the Authority. The White Paper on Food Safety initially set three general tasks for EFSA: the provision of scientific advice and information for the Commission on all matters having a direct or indirect impact on consumer health and safety arising from the consumption of food, the work already undertaken by the scientific committees to be a core part of this process; information gathering and analysis, in particular through taking a proactive role in developing and operating food safety monitoring and surveillance programmes; and communicating directly and openly with consumers on food issues to give the Authority a high profile, so that it ultimately becomes the automatic first port of call when scientific information on food safety and nutritional issues is sought or problems have been identified. These three general tasks are designed to facilitate EFSA in carrying out the more specific responsibilities relating to crisis reaction and national and international networking with the national scientific agencies and institutions in charge of food safety. According to the White Paper, the three key elements that are to underpin all activities of EFSA and the scientific committees, and that are to be used as criteria by the Community institutions when determining the nature and admissibility of scientific advice to decision-making, are ‘independence, excellence and transparency’. This is essential to re-establish consumer confidence in the food industry. The three criteria are to be satisfied by all scientific research that is used to direct legislative or judicial action. These benchmarks are not clearly defined in the White Paper. They remain subjective and abstract in their application. However, it is stated that the Authority must act ‘independently of outside pressures’ and that it must be ‘representative and accountable’, the impartiality of the Authority’s work in this regard to be assessed by the Commission. Key to ensuring this independence is the selection of the head of the Authority. Excellence is to be ensured primarily by ‘the identification and recruitment of the highest calibre of personnel’. Transparency: involves not only the rapid, open presentation of the findings and recommendations of the Authority, but also implies that the processes followed in reaching them are as open as possible, in order to respond to the fundamental right of access of citizens as laid down in the Treaty [requiring] clear procedures, publicly available, governing the operation of the Authority.20

Regulation 178/2002 on the General Principles of Food Law EFSA was established, following the proposals put forward in the White Paper on Food Safety, by Regulation 178/2002.21 The preamble to the regulation states that the scientific and technical basis of Community legislation relating to the safety of 20

Ibid, section 43. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety. [2002] OJ L 31/1. 21

(F) MacMaolin Ch5

9/2/07

15:16

Page 188

188 Food Safety in the EU food and feed should contribute to the achievement of a high level of health protection within the Community. To facilitate this, the Community should have access to high-quality, independent and efficient scientific and technical support. The establishment of a European Food Safety Authority would reinforce the system of scientific and technical support already in place, a system that, it was recognised, was no longer able to respond to the increasing demands placed upon it. Pursuant to the general principles of food law, also set out in the regulation, the Authority should take on the role of an independent scientific point of reference in risk assessment and, in so doing, assist in the smooth functioning of the internal market. It would carry out this role by giving opinions on contentious scientific issues, thereby enabling the Community institutions and the Member States to take informed risk management decisions necessary to ensure food and feed safety, whilst also helping to avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to free movement. Whilst the Authority is to be an independent source of advice, information and risk communication to ensure consumer confidence, the Preamble to the regulation also states that in order to promote coherence between the risk assessment, risk management and risk communication functions, the link between risk assessors and risk managers should be strengthened. The terms of reference set for the Authority initially appear to be both broad in scope and ambitious in aspiration. It is to provide a comprehensive scientific view of the safety and other aspects of the food and feed supply chains, including animal health and welfare and plant health, and it is to provide scientific advice and support on human nutrition in relation to Community legislation and health programmes. However, it is stated that the Authority is to focus on food safety issues and, as such, its mission in relation to animal health, animal welfare and plant health issues that are not linked to the safety of the food supply chain is to be, or at least should be, limited to the provision of scientific opinions. Chapter III of Regulation 178/2002 sets out the provisions governing the establishment and functioning of EFSA. The mission statement setting the aims for the Authority includes: providing scientific advice and technical support for the Community’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety; providing independent information on all matters within these fields and communicating on risks; contributing to a high level of protection of human life and health, taking account of animal health and welfare, plant health and the environment, in the context of the operation of the internal market; collecting and analysing data to enable food and feed risks to be monitored; providing scientific advice and technical support on human nutrition in relation to Community legislation and assisting on nutritional issues within the framework of the Community health programmes; providing scientific opinions on other matters relating to animal health and welfare and plant health and on products other than food and feed relating to genetically modified organisms; providing a point of reference based on independence, information quality and transparency; co-operating with similar authorities in the Member States; and

(F) MacMaolin Ch5

9/2/07

15:16

Page 189

5.2 The BSE Crisis 189 co-operating with the Commission and the Member States to promote the effective coherence between risk assessment, risk management and risk communication.22 The tasks set for the Authority that will enable it to carry out its mission include: providing the Community institutions and the Member States with the best possible scientific opinions in all cases provided for by Community legislation and on any question within its mission; promoting and co-ordinating the development of uniform risk assessment methodologies in the fields falling within its mission; providing scientific and technical support to the Commission in the areas within its mission and, when so requested, in the interpretation and consideration of risk assessment opinions; commissioning scientific studies necessary for the accomplishment of its mission; searching for, collecting, collating, analysing and summarising scientific and technical data in the fields within its mission; undertaking action to identify and characterise emerging risks, in the fields within its mission; establishing a system of networks of organisations operating in the fields within its mission and being responsible for their operation; providing scientific and technical assistance, when requested to do so by the Commission, in the crisis management procedures implemented by the Commission with regard to the safety of food and feed; providing scientific and technical assistance, when requested to do so by the Commission, with a view to improving co-operation between the Community, applicant countries, international organisations and third countries, in the fields within its mission; ensuring that the public and interested parties receive rapid, reliable, objective and comprehensive information in the fields within its mission; expressing independently its own conclusions and orientations on matters within its mission; and undertaking any other task assigned to it by the Commission within its mission.23 These tasks generally reflect the original aspirations set out for the Authority in the White Paper on Food Safety.24 Structure of EFSA EFSA, which has legal personality,25 consists of a management board, an executive director and his staff, an advisory forum, and a scientific committee and scientific panels.26 The management board comprises 14 members appointed by the Council in consultation with the European Parliament, from a list drawn up by the Commission, as well as a representative of the Commission. Four of the 14 are from organisations representing consumers and other interests in the food chain. Each member’s term of office is four years and may be renewed once. Decisions are taken on a majority basis, one of the members being elected chair by the others 22

Article 22. Article 23. 24 For further discussion on the status of EFSA see K Kanska, ‘Wolves in the Clothing of Sheep? The Case of the European Food Safety Authority’ (2004) 29 European Law Review 711. 25 Article 46. 26 Article 24. 23

(F) MacMaolin Ch5

9/2/07

15:16

Page 190

190 Food Safety in the EU for a two-year period, meetings taking place when requested by the chair or by at least one third of the members. One of the key functions of the management board is to ensure that the Authority carries out its mission and performs the tasks assigned to it. They also adopt the Authority’s programme of work for the coming year, as well as a revisable multi-annual programme, on an annual basis. The executive director takes part in meetings of the management board, but does not have voting rights.27 The executive director is appointed by the management board from a list proposed by the Commission following an open competition. The executive director is the legal representative of the Authority and is responsible for the day-to-day administration of the Authority; drawing up proposals for the Authority’s work programmes; implementing the work programmes and decisions adopted by the management board; ensuring the provision of the appropriate scientific, technical and administrative support for the scientific committee and the scientific panels; ensuring that the Authority carries out its tasks in accordance with the requirements of its users, in particular with regard to the adequacy of the services provided and the time taken; preparing the statement of revenue and expenditure and executing the Authority’s budget; developing and maintaining contact with the European Parliament; and ensuring regular dialogue with its relevant committees.28 The advisory forum is composed of representatives from competent bodies in the Member States which undertake tasks similar to those of the Authority itself, on the basis of one representative per Member State. Members of the advisory forum may not be members of the management board. The forum is to advise the Director, in particular on the drawing up of proposals for the Authority’s work programme. A system of co-operation between the competent bodies and the Authority is envisaged in the regulation. Another function of the forum is to ensure that, where possible, this happens, in particular to ensure that duplication is avoided between the Authority’s scientific studies and those of the Authorities in the Member States and to maximise the possibility of identifying emerging risks. The forum meets at least four times a year, either at the invitation of the chair (the executive director of EFSA) or at the request of at least one third of its members. Representatives of both the Commission and the European Parliament may participate in the work of the advisory forum, usually at the invitation of the executive director.29 The scientific committees and scientific panels are responsible for providing the scientific opinions of the Authority, each within their own spheres of competence. Where subjects do not fall within the competence of any of the established scientific panels, the scientific committee is to set up working groups to establish scientific opinions. The scientific committee is composed of the chairs of the individual panels and six independent scientific experts who do not belong to any of 27 28 29

Article 25. Article 26. Article 27.

(F) MacMaolin Ch5

9/2/07

15:16

Page 191

5.2 The BSE Crisis 191 the panels. The panels themselves are composed of independent scientific experts. Under the terms of the regulation, panels are to be formed on: food additives, flavourings, processed aids and materials coming into contact with food; additives and products or substances used in animal feed; plant health, plant protection products and their residues; genetically modified organisms; dietetic products, nutrition and allergies; biological hazards; contaminants in the food chain; and animal health and welfare. Representatives of the Commission may be present at meetings of the scientific committee, the scientific panels and their working groups, but only to clarify information. They may not influence decisions at these meetings in any way.30 EFSA and Scientific Opinions EFSA issues scientific opinions either at the request of the Commission, or where Community legislation makes provision for the Authority to be consulted. It may also deliver such opinions on its own initiative on matters falling within its remit or at the request of the European Parliament or a Member State.31 Where EFSA identifies that there may be divergence between its own scientific opinion and that of others, it is to contact the bodies involved in order to ensure that all relevant scientific information is shared and to identify potentially contentious scientific issues. Where a substantive divergence is identified and the body in question is a Community agency or one of the Commission’s scientific committees, that Authority and the body concerned are to co-operate with a view to either resolving the divergence or presenting a joint document to the Commission, a document that is also to be made public, clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. Where the diverging body is a Member State body, the Authority and the Member State body must co-operate in a similar manner.32 EFSA is to be informed not only by commissioning scientific studies but also by collecting relevant data that may assist in the early identification of potential risks to human health. For example, it is to collect, collate, analyse and summarise relevant scientific and technical data, in the fields within its mission, in particular on: food consumption and the exposure of individuals to risks related to the consumption of food; incidence and prevalence of biological risk; contaminants in food and feed; and residues.33 Where the Authority has information which leads it to suspect that there is an emerging serious risk, it is to request additional information from the Member States, other Community agencies and the Commission. The Authority is then to assess all the information at its disposal to identify the extent, if any, of the risk. This information is then forwarded to the 30 31 32 33

Article 28. Article 29. Article 30. Article 33.

(F) MacMaolin Ch5

9/2/07

15:16

Page 192

192 Food Safety in the EU European Parliament, the Commission and the Member States.34 To assist in this, and other EFSA processes, the Authority is to promote the networking of European organisations operating within the field in order to facilitate a scientific co-operation framework by the co-ordination of activities, the exchange of information, the development and implementation of joint projects and the exchange of expertise and best practices within the field. This process commences with the drawing up of a list of the competent organisations designated by the Member States which could assist the Authority, either individually or in networks.35 Independence and transparency in decision-making are central to the operations of EFSA. All acts must be in the public interest, free from any external influence.36 The independence of these activities must be clear to all, therefore the minutes of scientific committee and panel meetings, their decisions (including those of dissenters), the information on which these decisions are based, declarations of the interests of members, the results of studies, annual reports and requests made of EFSA that were refused, such as those from the European Parliament, the Commission or the Member States, and the reasons for any such refusal, are all to be made public without unnecessary delay. Similarly, meetings of the management board are, in general, to be held in public, and in some circumstances consumer representatives or other interested parties may be invited to observe proceedings.37 Some information which the Authority receives, in particular where this has been requested and justified, is to be kept confidential.38 However, the conclusions of the scientific opinions delivered by the Authority relating to foreseeable health effects are never to be kept confidential for any reason.39 In fact, the Authority is to ensure that the public and any interested parties are to be given objective, reliable and easily accessible information, in particular with regard to the results of its work.40 There is also to be wide access to Authority documents, and those which it possesses.41 Rapid Alert System, Crisis Management and Emergencies In addition to establishing EFSA, Regulation 178/2002 codifies the Community rapid alert system, which is designed to enable it to react to food crises and emergencies. The system involves EFSA, the Commission and the Member States, who all designate a contact point, which is to be a member of this rapid alert network. Where a member of the network has any information relating to the existence of a serious direct or indirect risk to human health deriving from food or feed, this 34 35 36 37 38 39 40 41

Article 34. Article 36. Article 37. Article 38. Article 39. Ibid. Article 40. Article 41.

(F) MacMaolin Ch5

9/2/07

15:16

Page 193

5.2 The BSE Crisis 193 information is to be immediately notified to the Commission under the rapid alert system. The Commission is then to transmit this information immediately to the members of the network. EFSA can then supplement this notification with any scientific or technical information that will facilitate rapid, appropriate risk management action by the Member States.42 Under the rapid alert system the Member States must immediately notify the Commission when they adopt a measure which is aimed at restricting the placing on the market or forcing the withdrawal from the market or the recall of food or feed in order to protect human health and requiring rapid action. Similarly, such notification must be made when any recommendation or agreement with professional operators which is aimed, on a voluntary or obligatory basis, at preventing, limiting or imposing specific conditions on the placing on the market or the eventual use of food or feed on account of a serious risk to human health requiring rapid action or any rejection, relating to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the European Union. Any such notification is to be accompanied by a detailed explanation of the reasons for the action taken. This information, and any supplementary data, is then passed on by the Commission to the entire network and to a third country where relevant. The Member States must in turn inform the Commission of any action that they take on the basis of this information. Participation in the rapid alert system may also be opened up to applicant countries, third countries and international organisations, in accordance with agreements between the Community and these organisations or States, and, for the former, where there is some form of reciprocal agreement.43 Information that is available to the members of the network relating to a risk to human health posed by food and feed is, generally, to be made available to the public, including details of product identification, the nature of the risk and the measures taken.44 Where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that this risk cannot be contained satisfactorily by measures taken by the Member States concerned, then the Commission, either on its own initiative or at the request of a Member State, can adopt one of several emergency measures, the measure adopted being dependent on the gravity of the situation. These measures include, for food or feed of Community origin: suspending the placing on the market or use of the food or feed in question; laying down special conditions for use of the food or feed; or any other appropriate measure. For feed or food from a third country: suspending the importation of the food or feed from the, or part of the, country concerned or the third country of transit where applicable; laying down special conditions for the food or feed; or any other appropriate interim measure. The chosen measure is to be taken under 42 43 44

Article 50. Ibid. Article 52.

(F) MacMaolin Ch5

9/2/07

15:16

Page 194

194 Food Safety in the EU the procedure set out in Article 5 of Decision 1999/468.45 However, in some emergencies the Commission may provisionally adopt these measures after consultation with the Member States concerned for up to 10 working days, after which time they must be confirmed, amended, revoked or extended.46 Where a Member State informs the Commission of the need to take emergency measures and the Commission does not act, the Member State may adopt interim protective measures, provided that it informs the other Member States and the Commission of any decision taken in this regard.47 The Commission then has 10 days to put the matter to the Standing Committee on the Food Chain and Animal Health under the Decision 1999/468 procedure,48 with a view to the extension, amendment or abrogation of the national interim protective measures.49 The Member State may maintain these interim measures until any Community measures have been adopted.50 Where any Member State is of the opinion that a measure taken by another Member State is incompatible with any of the terms of the regulation or is likely to affect the functioning of the internal market, it is to refer the matter to the Commission, which is then to meet with the Member States concerned in an attempt to reach agreement on the matter, with, where necessary, the help of the Authority.51 In addition to the procedures and processes put in place for taking emergency measures, the regulation also stipulates that the Commission, EFSA and the Member States are to devise a general plan for food and feed safety crisis management.52 This general plan is to specify those situations where the risks posed are unlikely to be prevented, eliminated or reduced by the emergency measures system. It is also to specify the practical procedures necessary to manage a crisis, including the principles of transparency to be applied and a communication strategy.53 Provision is made for the Commission to identify additional potential serious risks.54 In an identified crisis, the Commission is to set up a crisis unit, which is to be assisted by EFSA if necessary.55 This unit is responsible for collecting and evaluating all relevant information and identifying the options available to minimise the risk, and communicating details of this, and any measures to be taken, to the public.56 They may be assisted in this regard by any public or private person whose expertise can assist in managing the crisis effectively.57 45 Article 53(1) in conjunction with Article 58(2) of Regulation 178/2002. Comitology Decision reference: Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. [1999] OJ L 184/23. 46 Article 53(2). 47 Article 54(1). 48 Articles 7 and 8 thereof. See Article 58 of Regulation 178/2002. 49 Article 54(2). 50 Article 54(3). 51 Article 60. 52 Article 55. 53 Article 55(2). 54 Article 56(1). 55 Article 56(2). 56 Article 57(3). 57 Article 57(2).

(F) MacMaolin Ch5

9/2/07

15:16

Page 195

5.3 The Precautionary Principle 195 The White Paper on Food Safety and its key outcome, the establishment of EFSA, have put in place a detailed set of procedures for dealing with those circumstances where a potential food crisis needs to be averted. The development of this risk management system should certainly assist in consolidating efforts and furthering co-operation between the Authority, the Member States and the Commission. However, two key problems persist. First, Member States remain limited in the action that they can take at national level where a domestic food crisis occurs. The manner in which the case law on Articles 28 to 30 EC has developed effectively leaves any such action open to challenge as to its lawfulness where this inhibits free movement in any way—as was identified to be the case by the inquiry into the outbreak and control of BSE in the UK. Second, all the procedures and processes continue to relate to identifiable and imminent dangers to human health due to contamination or disease. Nutritional content and potential risks that may arise due to the harmful ingredients of a food product, such as sodium, sugar and trans fatty acids, remain firmly outside the remit of EFSA and EU food safety policy more generally.58 While some specific Community legislation addressing some of these concerns does exist, for example concerning the use of additives in food, we will see below that in line with most of the activities of the Community institutions relating to the production and marketing of food, this exists primarily to promote free movement rather than to ensure that food is of a particular quality level or safe to eat. 5.3 USING THE PRECAUTIONARY PRINCIPLE TO PROTECT HUMAN HEALTH

One of the more influential consequences for food safety arising out of the BSE crisis has been the extension of what is known as the precautionary principle from environmental law into actions taken to protect human health.59 Essentially, the principle enables the Community institutions to restrict the use of a product or procedure where this could potentially have detrimental consequences for the safety of food where some scientific evidence is presented to support this action. The data must be sufficient, but need not be either undisputed or conclusive. The use of this principle in environmental law was first formally sanctioned by the London Declaration on the Protection of the North Sea in 1987 and the Bergen Ministerial Declaration on Sustainable Development in 1990.60 It was accorded 58 The fact that the EU has failed to act on matters such as trans fatty acids makes it easier for Member States to introduce their own measures on this to protect human health, provided they can be justified. This is discussed further in Chapter 6 below. 59 For further discussion on the use of the precautionary principle in EU law see KH Ladeur, ‘The Introduction of the Precautionary Principle into EU Law: A pyrrhic victory for environmental and public health law? Decision-making under conditions of complexity in multi-level political systems’ (2003) 40 Common Market Law Review 1455; J Cazala, ‘Food Safety and the Precautionary Principle: the legitimate moderation of Community courts’ (2004) 10 European Law Journal 539; and M Lee, EU Environmental Law: Challenges, Change and Decision-Making (Oxford, Publishing, 2005). 60 The initial development of the precautionary principle is generally credited to West German policies of the 1970s. The approach was then used to justify the implementation of various measures to tackle acid rain, global warming and the pollution of the North Sea. For further discussion see

(F) MacMaolin Ch5

9/2/07

15:16

Page 196

196 Food Safety in the EU full EC Treaty status in 1993. Article 174(2) EC states that Community policy on the environment: shall be based on the precautionary principle and on the [principle] that preventive action should be taken.

The precautionary principle is not itself defined anywhere in the Treaty. It is not specifically defined in any other Community legislation either. Some further guidance on how and when the principle may be used is contained in a Commission communication on the subject.61 The Communication states that the precautionary principle is to be used within a structured approach to the analysis of risk, which comprises three elements: risk assessment, risk management and risk communication. The principle is usually invoked through the management process, usually resulting in the introduction of measures prohibiting or limiting the use of a suspected product or procedure. The Communication has been described as being a codification of the law relating to the precautionary principle.62 The initial steps taken towards extending the precautionary principle from environmental law into human health protection were taken by the Court of Justice in UK v Commission 63 and Queen v National Farmers’ Union.64 It was stated in both judgments, which examined the legitimacy of Community measures designed to protect the spread of BSE, that: Where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent.65

Legislative support for developing the principle in this way was offered by a new interpretation of Article 174(1) EC. It was stated that: [the purpose of] Article 130r(1) of the EC Treaty [now Article 174(1) EC] [determines that] Community policy on the environment is to pursue the objective inter alia of protecting human health. Article 130r(2) [now Article 174(2) EC] provides that that policy is to aim at a high level of protection and is to be based in particular on the principles that preventive action should be taken and that environmental protection requirements A Jordan, ‘The Precautionary Principle in the European Union’ in T O’Riordan, J Cameron and A Jordan (eds), Reinterpreting the Precautionary Principle (London, Cameron May, 2001). The first explicit references to the precautionary principle at international level appeared in the 1985 Vienna Convention on Ozone Depleting Substances and the Declaration of the Second International North Sea Conference on the Protection of the North Sea (the London Declaration). The participants at the North Sea Conference declared that they accepted that ‘in order to protect the North Sea from possibly damaging effects of the most dangerous substances, a precautionary approach is necessary, which may require action to control inputs of such substances even before a causal link has been established by absolute clear scientific evidence’. Paragraph VII, London Declaration, 25 November 1987. 61 Communication from the Commission on the Precautionary Principle, 2 February 2000. COM (2000) 1. 62 Case T-13/1999, Pfizer Animal Health SA v Council [2002] ECR II-3305, para 149. 63 Case C-18/1996, United Kingdom v Commission (BSE) [1998] ECR I-2265. 64 Case C-157/1996, Queen v National Farmers’ Union [1998] ECR I-2211. 65 Case C-18/1996, UK v Commission, note 63 above, para 99 and Case C-157/1996, Queen v National Farmers’ Union, note 64 above, para 63. Both judgments were issued on the same day.

(F) MacMaolin Ch5

9/2/07

15:16

Page 197

5.3 The Precautionary Principle 197 must be integrated into the definition and implementation of other Community policies.66

The Court was thus suggesting that there was a connection between Article 174 EC and the protection of human health in areas not directly related to the protection of the environment. This is not the case. The Treaty does state that environmental protection measures should be designed in a manner that protects human health and that environmental protection requirements should be integrated into the definition and implementation of other Community policies. This does not mean that principles of environmental law may be used in areas of Community policy that are not related in any way to the environment, such as food safety. Preventing the contamination of the human food chain with meat from BSE-infected cattle does not come within the scope of Article 174 EC. It is not an environmental protection issue. Article 152 EC, which does state that: Community action . . . shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health,

could be used to lawfully extent the right to take precautionary action in human health related matters. It should be noted that Article 152 EC did not exist in its current form until after the entry into force of the Treaty of Amsterdam in May 1999, almost a year after the judgments in UK v Commission and Queen v National Farmers’ Union were issued, extending the principle to non-environmental law related matters. Prior to this alteration the treaty merely stated that the function of the Community in this area was: to contribute towards ensuring a high level of human health protection by encouraging co-operation between the Member States and, if necessary, lending support to their action.

The Commission has since stated that: [although] the only explicit reference to the precautionary principle is to be found in the environment title of the EC Treaty, and more specifically Article 174 . . . one cannot conclude from this that the principle applies only to the environment.

To support this statement the Commission cites Article 6 EC, which provides that: Environmental protection requirements must be integrated into the definition and implementation of the Community policies referred to in Article 3, in particular with a view to supporting sustainable development,

as well as Article 95(3) EC, which provides that: The Commission, in its proposals . . . concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking

66 Case C-18/1996, UK v Commission, note 63 above, para 100 and Case C-157/1996, Queen v National Farmers’ Union, note 64 above, para 64.

(F) MacMaolin Ch5

9/2/07

15:16

Page 198

198 Food Safety in the EU account in particular of any new development based on scientific facts . . . [T]he European Parliament and the Council will also seek to achieve this objective.67

It is here contended that neither Article 6 EC nor Article 95(3) EC supports the advancement of the precautionary principle beyond environmental matters to include food safety. The former refers specifically to the environment. The latter refers only to scientific fact, not supposition. This extension should be allowable under an interpretation of Article 152 EC and not on the existing claimed legal basis.

5.3.1 Evidence Requirements There must always be a comprehensive scientific evaluation of potential risk prior to invocation of the precautionary principle. This is risk assessment. Scientific evidence must sufficiently demonstrate that there exists a possible risk to human health. Where this is the case, this assessment can be used to instruct and facilitate the taking of action to prevent or minimise this risk. This is risk management. The Commission Communication on the Precautionary Principle states that: An assessment of risk should be considered where feasible when deciding whether or not to invoke the precautionary principle [which] requires reliable scientific data and logical reasoning, leading to a conclusion which expresses the possibility of occurrence and the severity of a hazard’s impact on [human] health.

The risk management decision is taken by the bureaucrat or politician following consideration of the evidence presented in the risk assessment. Any measure adopted in this way must be proportionate, non-discriminatory, consistent with previous similar decisions and cost effective.68 While it is clear that there must be scientific substantiation supporting precautionary action, it is not entirely clear as to the amount or level or consensus on this evidence that must exist for measures enacted to be considered lawful. The most comprehensive assessment of these questions to date was conducted by the Court of First Instance in Pfizer.69 Here, the Court examined the validity of Regulation 2821/1998, which prohibited the use of four, previously approved, antibiotics in animal feed.70 The applicant, who was the only producer in the world of one of the banned antibiotics listed, sought the annulment of the regulation under the Article 230(4) EC procedure. The regulation had been introduced to counter fears that 67

Communication from the Commission on the Precautionary Principle. COM (2000) 1. Ibid. Case T-13/1999, Pfizer v Council, note 62 above. Judgment was delivered on the same day in Case T-70/1999, Alpharma Inc v Council [2002] ECR II-3495, where the applicant was also challenging the validity of Regulation 2821/1998. This application for annulment was also rejected by the Court of First Instance on similar grounds, albeit on slightly different facts. 70 Council Regulation (EC) No 2821/1998 of December 17 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 1970/524 concerning additives in feedingstuffs. [1998] OJ L 351/4. 68 69

(F) MacMaolin Ch5

9/2/07

15:16

Page 199

5.3 The Precautionary Principle 199 the continued use of these antibiotics in animal feed could make them resistant to the beneficial properties of the medication, and that this resistance could then be transferred to humans via the food chain. This could potentially result in a reduction in the effectiveness of these antibiotics in human medicine. It was agreed by all parties to the proceedings that at the time of the adoption of the contested regulation neither the reality nor the seriousness of the risk had been scientifically proven. The Council had thus relied upon the precautionary principle as justification for adopting the regulation. The applicant’s main argument was that the precautionary principle had been incorrectly applied in this case, in particular due to the fact that the risk assessment, which must be carried out prior to the introduction of any precautionary measures, was incomplete and erroneous. It was thus for the Court to establish what the composition of a risk assessment that is subsequently used to validate employment of the precautionary principle should be, in particular in circumstances such as those under review here, where the assessment ultimately allows the introduction of an outright prohibition on the use of a previously approved product or procedure. In particular, it was necessary to test whether there had been a manifest error or a misuse of power in the introduction of the contested regulation due to either a misapplication of the precautionary principle and/or an illegitimate reinterpretation of the scientific evidence used to support the prohibition introduced. After a detailed examination of the facts leading to the introduction of the contested regulation, the Court decided that sufficient evidence and information had been available to the Council to justify taking the precautionary measure that it had. The applicant’s contention that an improper assessment of the scientific data rendered Regulation 2821/1998 unlawful was rejected. The application to annul was thus dismissed. It was not in dispute that the precautionary principle was relevant to the circumstances under review in Pfizer. Noting the decisions in UK v Commission and Queen v National Farmers’ Union, it was accepted that where there is scientific uncertainty as to the existence or extent of risks to human health the Community institutions may, by reason of the existence of this principle, take protective measures without having to wait until the reality and seriousness of those risks become fully apparent.71 The applicant, however, contended that the compulsory risk assessment must demonstrate that the risk, although not yet a reality, was nevertheless probable, at least to a very remote degree. Thus the precautionary principle could not, it was claimed, be used to permit the introduction of a measure based upon what was termed a ‘zero risk test’, the applicant asserting that such an assessment would be inappropriate as it would be impossible to satisfy. To apply such a test would quickly lead to the paralysis of technological development and innovation.

71 See also Case T-199/1996, Laboratoires pharmaceutiques Bergaderm SA and Jean-Jacques Groupil v Commission [1998] ECR II-2805.

(F) MacMaolin Ch5

9/2/07

15:16

Page 200

200 Food Safety in the EU When questioned at the hearing about the level of verification that should be required in order to justify the withdrawal of the authorisation to use the antibiotics in animal feed, that applicant stated that ‘[i]t would be proven with the first infection, or with the first proof of colonisation, or the first proof of transfer in a human’. The Court found that this statement was based upon an incorrect interpretation of the precautionary principle as it had developed. It was found that the Community institutions are not required to wait for the adverse effects of a product to materialise before taking action designed to prevent them from occurring in the first place.72 Thus where the precautionary principle is applied, a risk assessment cannot be required to provide the Community institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality. The purpose of a risk assessment is to calculate the degree of probability of a certain product or procedure having adverse effects on human health and the potential seriousness of any such adverse effects. The risk assessment has two components: the ascertainment of the level of risk that is unacceptable, and the scientific assessment of the risks.73 The level of risk deemed unacceptable is to be determined by the Community institutions on a case by case basis. Several factors must be taken into account when making any such decision, including a general requirement that the political objectives of the EC Treaty are adhered to.74 More specifically, there must be an assessment of the severity of the impact on human health were the risk to occur, the extent to which there may be possible adverse effects, the reversibility of any adverse effects, and the possibility of delayed effects.75 The second component, the scientific assessment of the risk, presents a greater difficulty. The precautionary principle may only be invoked where scientific opinion on the potential risk conflicts. It was the scientific component of the risk assessment that proved the most contentious in Pfizer, primarily because the applicant sought justification for the fact that the Community institutions had chosen to accept one body of scientific opinion on the potential risk posed over another, leading directly to the introduction of the contested prohibition. What made this selection even more controversial was the fact that the Commission, and subsequently the Council acting on its advice, had reinterpreted the unambiguous findings of a Community scientific committee to illustrate that the use of the antibiotic produced by the applicant in animal feed presented an imminent danger to human health. They were also both aware that new evidence presented supporting the introduction of the contested regulation was gathered in a process that suffered from ‘methodological limitations’.

72 73 74 75

Case T-13/1999, Pfizer, para 381. Case C-355/1990, Commission v Spain (conservation of wild birds) [1993] ECR I-4221. Case T-13/1999, Pfizer, para 151. Ibid, para 153.

(F) MacMaolin Ch5

9/2/07

15:16

Page 201

5.3 The Precautionary Principle 201 5.3.2 Legislature and Scientific Committees Scientific advice is deemed to be ‘of the utmost importance at all stages of the drawing up of new legislation and for the execution and management of existing legislation’.76 The duty imposed on the Community institutions by Article 152 EC means that they must ensure that their decisions are taken in the light of the best scientific information available and that they are based on the most recent results of international research.77 The applicant in Pfizer submitted that the contested regulation was unlawful because of the inadequate nature of scientific data provided by the Danish authorities supporting a ban on the use of antibiotics in animal feed, and because a Scientific Committee for Animal Nutrition (SCAN) report, which had concluded that there was no immediate risk posed, had been reinterpreted and used as evidence to support the introduction of the prohibition, without any further consultation with the scientific committee. The Court noted that the role to be played by a committee of experts, such as SCAN, in the legislative process is restricted to presenting a reasoned analysis of the relevant facts of the case in the light of current knowledge about the subject, in order to provide the institutions with the factual knowledge required to enable them to make an informed decision.78 The institutions are not bound to follow the Committee’s opinion. However, where a Community institution chooses to disregard the opinion of a scientific committee in circumstances such as those at issue in Pfizer, it must provide specific reasons for this.79 This statement of reasons must be of a scientific level equivalent to that of the opinion, being founded upon either a supplementary opinion from the same committee of experts or other evidence, whose probative value is at least commensurate with that of the opinion first presented. Where the Community institution disregards only part of the opinion, it may use those parts that it does not dispute.80 The institutions may thus disregard the overall conclusions of the scientific committee report, even where they have relied on parts of the analysis. This position is deemed justifiable on grounds of principle relating to the political responsibilities and democratic legitimacy of the Commission. It was stated by the Court of First Instance that the members of SCAN may have scientific legitimacy, but they have neither democratic nor political responsibilities, the Commission’s democratic responsibility being based upon Article 211 EC. The Council was deemed to have explained its decision to depart from the SCAN opinion on the ground that it was in the interests of human health protection. Consequently, the Community legislature are not acting in error when they refuse to accept, or when they reinterpret, the findings of their scientific committees. There is no obligation to consult with the scientific committee 76 77 78 79 80

Commission Communication on Consumer Health and Food Safety. COM (1997) 183. Case T-13/1999, Pfizer, para 158. Ibid, para 197. Ibid, para 199. Ibid.

(F) MacMaolin Ch5

9/2/07

15:16

Page 202

202 Food Safety in the EU if new evidence emerges, even where this committee is of the opinion that this data is misleading.81 The assertion made by the applicants in Pfizer that the Community institutions are compelled to wait for the adverse effects of a product to materialise before taking precautionary action was correctly rejected. If this were not the case, the principle itself would be of little use. However, it is also clear that sufficient, even if contradicted, scientific evidence must be presented to support the introduction of precautionary measures. Where legislation, such as Directive 1970/524 on the use of additives in animal feed, suggests that a scientific committee should be consulted for its judgment as to any potential risk that may be posed by using antibiotics in this way, then this should probably happen.82 It has also been contended elsewhere that consultation with scientific committees on issues affecting consumer health and safety is preferred, even where the relevant Community legislation is silent on this point.83 This is necessary to ensure, as far as possible, that any scientific advice resorted to by the Commission is based upon the principles of excellence, independence and transparency, which are explicitly required by Decision 1997/579 establishing these scientific committees.84 The Commission failed in relation to this on two occasions in the introduction of Regulation 2821/1998. First, the initial unambiguous assessment made by SCAN concluding that there was no immediate risk posed to human health by the continued use of the antibiotic in animal feed was reinterpreted, this reinterpretation forming the basis for justifying the introduction of precautionary measures. Secondly, SCAN was not re-consulted after other, questionable, evidence emerged. Accepting this type of behaviour weakens the precautionary principle. It demonstrates that its application can be arbitrary and uncertain.85 It bypasses the foundation of any precautionary action—the fact that a sufficiently thorough risk assessment identifying the need for risk management must exist before any such action can take place. Where the Commission lacks the knowledge required to assess this scientific evidence it must consult with the appropriate scientific committee in order to ensure that Community measures taken to protect human health are appropriate to that objective.86 Any other approach undermines the essential role that sound 81

Case T-13/1999, Pfizer, para 299. Council Directive 1970/524 of 23 November 1970 concerning additives in feedingstuffs. [1970] OJ L 270/1. 83 E Vos, ‘EU Committees: The Evolution of Unforeseen Institutional Actors in European Product Regulation’ in C Joerges and E Vos (eds), EU Committees: Social Regulation, Law and Politics (Oxford, Hart Publishing, 1999). See also G de Búrca, ‘The Institutional Developments of the EU: A Constitutional Analysis’ in P Craig and G de Búrca (eds), The Evolution of EU Law (Oxford, OUP, 1999), in particular pp 71–75 thereof. 84 Commission Decision 1997/579 setting up scientific committees in the field of consumer health and food safety. [1997] OJ L 237/18. 85 This also increases the risk of precautionary EU measures acting contrary to the WTO Agreement on the Application of Sanitary and Phytosanitary Measures. For further discussion see N Salmon, ‘A European Perspective on the Precautionary Principle, Food Safety and the Free Trade Imperative of the WTO’ (2002) 27 European Law Review 138–55. 86 Case C-212/1991, Angelopharm GmbH v Freie Hansestadt Hamburg [1994] ECR I-171. 82

(F) MacMaolin Ch5

9/2/07

15:16

Page 203

5.4 Community Food Safety Legislation 203 science is expected to play at all stages of the legislative process. It effectively limits scientific opinion to the risk assessment stage, leaving risk management to be monopolised by non-expert opinion. This apparent weakening of the position of scientific committees is all the more surprising when one considers the status that is accorded to these bodies through what is know as the ‘comitology procedure’, whereby the Commission, where provision is created, should be assisted by an advisory committee in the adoption of Community measures.87 While the Commission is not obliged to follow any advice given, it is required to take ‘the utmost account of the opinion delivered’. Regulation 178/2002, which established the regulatory Standing Committee on the Food Chain and Animal Health to replace the Standing Committee on Foodstuffs, the Standing Veterinary Committee and the Standing Committee on Animal Nutrition (as well as taking over certain tasks of the Standing Committee on Plant Health), also provides that the Commission may only adopt implementing measures if it obtains a favourable opinion from the Committee. While the regulation at issue in Pfizer was adopted by the Council, the provisions in Regulation 178/2002 do serve to illustrate the strengthened role of these committees in the legislative process. 5.4 COMMUNITY FOOD SAFETY LEGISLATION

The establishment of a European Food Safety Authority, the creation of rapid alert systems and measures to be taken in an emergency and empowering the Community institutions and the Member States to take the initiative in food safety matters on a precautionary basis, is only one aspect of the EU food safety programme. Ensuring not just that the food itself that is safe, but also that the manner in which it is packaged causes no harm, the prevention of contamination and control over processes that the foodstuff undergoes in production must all be dealt with as well.

5.4.1 Materials Coming into Contact with Foodstuffs The framework legislation controlling materials intended to come into contact with foodstuffs is Directive 1989/109.88 The key principle underlying the directive is that any material or article intended to come into contact either directly or indirectly with foodstuffs must be sufficiently stable that it does not transfer substances to the foodstuffs in quantities which could endanger human health or 87 Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. [1999] OJ L 184/23. 88 Council Directive 1989/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs. [1989] OJ L 40/38. This replaced Council Directive 1976/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs. [1976] OJ L 340/19.

(F) MacMaolin Ch5

9/2/07

15:16

Page 204

204 Food Safety in the EU bring about an unacceptable change in the composition of the foodstuffs or a deterioration in their organoleptic properties.89 The directive applies to all materials and articles which are intended to be brought into contact with foodstuffs, including water, but not including those covering or coating substances which form part of, and may be consumed with, the foodstuff, such as the substances covering cheese rinds, prepared meat or fruit.90 Materials must be manufactured in compliance with good practice to ensure that under normal conditions of use there is no transfer of their constituents to foodstuffs in dangerous quantities.91 The directive facilitates the introduction of further directives relating to specific materials coming into contact with foodstuffs,92 such as plastics, ceramics, glass, wood (including cork) and cellulose.93 Several such specific directives have since been introduced, generally to amend those rules already in existence under similar provisions of the preceding framework directive.94 These specific directives list those substances that can be used, and the quantities in which they may be used, in the manufacture of the materials that are permitted to come into contact with foodstuffs.95 Annex II to Directive 1989/109 sets out a series of general criteria relating to the protection of human health that are to be applied in the assessment and use of those substances that may come into contact with foodstuffs. It is stated that, where appropriate, positive lists of substances should be established for materials and articles intended to come into contact with foodstuffs, the acceptability for inclusion in such a list to be determined by considering both the quantity of the substance which is liable to migrate into foodstuffs and the toxicity of the substance. A substance is only to be included in a positive list where, under normal or foreseeable conditions of use, the substance is not liable to migrate into foodstuffs in a quantity likely to constitute a danger to human health. All substances are to be 89

Preamble 6 to Directive 1989/109. Article 1(1) and 1(2). 91 Article 2. 92 Article 3. 93 A full list of those materials and articles for which further specific legislative provisions may be introduced is set out in Annex I to Directive 1989/109. 94 See, for example, Council Directive 1984/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs, [1984] OJ L 277/12; Council Directive 1982/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, [1982] OJ L 297/26; Commission Directive 1993/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs, [1993] OJ L 93/27. 95 For example, Annex II in conjunction with Article 2 of Commission Directive 1993/10. Article 3(3) of Directive 1989/109 states that the specific directives may include a list of substances the use of which is authorised to the exclusion of all others (a positive list); purity standards for such substances; special conditions in which these substances may be used; specific limits on the migration of constituents into foodstuffs; detailed rules concerning the analysis of these substances; and, if necessary, provisions aimed at protecting human health against any potential hazards which might arise through contact with the materials. 90

(F) MacMaolin Ch5

9/2/07

15:16

Page 205

5.4 Community Food Safety Legislation 205 kept under review and reassessed whenever this is justified by fresh or re-evaluated scientific data.

5.4.2 Contaminants in Food Regulation 315/1993 establishes the framework for Community procedures relating to contaminants in food.96 A contaminant is defined as: any substance not intentionally added to food as a result of the production, manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food, or as a result of environmental contamination.97

This definition does not cover any extraneous matter, such as insect fragments or animal hairs, that may be present in the foodstuff.98 Any food containing a contaminant in an amount which is unacceptable from a public health perspective, in particular due to a higher than tolerable toxicological level, is not to be placed on the market.99 Where a contaminated product is placed on the market, the levels of contamination must be kept to a minimum,100 the maximum tolerance levels to be set by the Commission assisted by the Standing Committee for Foodstuffs.101 Member States may restrict the levels of contaminant further than those allowable under Community law in circumstances where, as a result of new information or a reassessment of existing information, they have reason to believe that there is a threat to human health.102 Commission Regulation 466/2001 sets a range of maximum acceptable levels for contaminants in foodstuffs.103 The regulation covers many potentially hazardous contaminants such as: cadmium, which may accumulate in the human body and lead to kidney disfunction, skeletal damage and reproductive deficiencies; lead, which, when absorbed by the body, can induce reduced cognitive development and intellectual performance in children and increased blood pressure and cardiovascular disease in adults; and mercury, which may detrimentally affect the development of the brains of infants and induce neurological changes in adults. The regulation mainly consists of a detailed annex listing maximum levels for certain contaminants in specific foodstuffs and details of the manner in which these foodstuffs are to be tested for the presence of contaminants; for example, the maximum level of lead that is permitted to be present in cows’ milk and/or infant 96 Council Regulation (EEC) No 315/1993 of 8 February 1993 laying down Community procedures for contaminants in food. [1993] OJ L 37/1. 97 Article 1(1). 98 Ibid. 99 Article 2(1). 100 Article 2(2). 101 Article 2(3) and Article 8. 102 Article 4. 103 Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs. [2001] OJ L 77/1.

(F) MacMaolin Ch5

9/2/07

15:16

Page 206

206 Food Safety in the EU formula is 0.02 mg per kg, the amount present to be tested under the Directive 2001/22 procedure.104 For cadmium there can be no more than 0.5 mg per kg present in cattle or pig liver and no more than 1 mg per kg in cattle or pig kidney, both to be tested under the Directive 2001/22 procedure. Mercury, which is generally found in fish, may be present up to a level of 0.5 mg per kg for all types, except those specifically listed in the Annex, such as tuna, bass and ray, as these may contain up to 1 mg per kg, again to be tested under the Directive 2001/22 procedure. Under this procedure all sampling is to be carried out by authorised qualified persons as specified by the Member States in laboratories that meet the minimum standards set by Directive 1993/99.105

5.4.3 Irradiated Foods Food may be physically treated with high-energy, ionising radiation to prolong its shelf life and/or to reduce health hazards associated with certain products due to the presence of pathogenic micro-organisms. For example, ionising radiation may, in some circumstances, prevent the germination and sprouting of potatoes, onions and garlic; disinfect grains, dried fruit, vegetables or nuts by killing or sterilising insects with which they are infested; delay the ripening and/or ageing of fruit and vegetables; prolong the shelf life of meat, poultry and seafood and prevent food-borne diseases by reducing the number of viable micro-organisms in them; and reduce the levels of micro-organisms in herbs and spices. Directive 1999/2 recognises that rules relating to the use of ionising radiation for the treatment of foodstuffs should take account primarily of human health requirements,106 but also—within these limits required for the protection of health—economic and technical needs.107 Foodstuffs treated with ionising radiation that are intended for the ultimate consumer or mass caterers must be labelled as such, under the terms set out in the framework food labelling directive. Where it is an ingredient that has been treated in this way, then attention must be brought to this fact in the list of ingredients, even if forming only part of a compound ingredient.108 A foodstuff treated with ionising radiation may not be imported from a third country unless it complies with the conditions set out in the Directive. These conditions include that, where applicable, the foodstuff in question has been treated in a Community-approved irradiation facility, and proper supporting doc104 Commission Directive 2001/22/EC of 8 March 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs. [2001] OJ L 77/14. 105 Council Directive 1993/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs. [1993] OJ L 290/14. 106 Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation. [1999] OJ L 6/16. 107 Preamble 6 to Directive 1999/2/EC. 108 Article 6.

(F) MacMaolin Ch5

9/2/07

15:16

Page 207

5.4 Community Food Safety Legislation 207 umentation is retained to establish this.109 Materials used for packaging irradiated foodstuffs must be suitable for this purpose.110 Annex I to Directive 1999/2 sets out the conditions for authorising food irradiation. It may only be authorised if there is a reasonable technological need, it presents no hazard to human health, it is of benefit to the consumer and it is not used as a substitute for hygiene and health practices. It may only be used to reduce the incidence of food-borne disease by destroying pathogenic organisms, to reduce spoilage of foodstuffs by slowing decay processes, to reduce loss of foodstuffs by premature ripening, germination or sprouting and to rid foodstuffs of organisms harmful to plants. Directive 1999/3 set a positive list of those foodstuffs that can be treated with maximum ionising radiation doses.111 The initial list contained only one category of authorised foodstuff—dried aromatic herbs, spices and vegetable seasonings.112 EU legislation on materials coming into contact with foodstuffs, contaminant levels and ionising radiation treatment all present a picture of the best interests of human health being served. For the most part, this is the case. Most of these controls, and the methods to be employed in determining whether the set standards are adhered to, are absolutely vital in ensuring that consumer confidence in the safety of food supplied remains high. While it is generally the case that EU food law seeks to keep harmful substances out of foodstuffs, there is always a balance to be struck with the economic needs of producers and in ensuring that supply levels remain high. As a consequence, some dangerous substances may remain in food, provided that they are kept at a tolerable level—that is, there should be no real threat to human health.

5.4.4 Hygienic Production Methods Standardised rules on the hygienic production and marketing of food are set out in Regulation 852/2004.113 It is noted in the preamble to the regulation that the protection of human life and health is one of the fundamental objectives of food

109

Article 9(1). Article 10. 111 Directive 1999/3/EC of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation. [1999] OJ L 66/24. 112 Annex to Directive 1999/3. The Scientific Committee on Food re-examined its 1986 stance on the irradiation of food in 2003, finding that the only technological need for this practice would be the decontamination of spices, dried herbs and vegetable seasonings, that it was still appropriate to specify a maximum dose for the treatment of certain food products by ionising radiation, and that irradiated foodstuffs should continue to be evaluated individually, taking into account the technological need and the safety of the process. Revision of the opinion of the Scientific Committee on Food on the irradiation of food. SCF/CS/NF/IRR/24 final, 24 April 2003. 113 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. [2004] OJ L 139/1. 110

(F) MacMaolin Ch5

9/2/07

15:16

Page 208

208 Food Safety in the EU law, as laid down in Regulation 178/2002.114 It is also noted here that the requirements of hygienic production methods set out in EU law should take account of the principles contained in the Codex Alimentarius General Principles of Food Hygiene.115 ‘Food hygiene’ is defined in the regulation as: the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use.116

The regulation is primarily aimed at food business operators.117 It is noted that the primary responsibility for food safety rests with them. This responsibility covers all those involved in the production, preparation and sale of food, starting with the primary production of the raw materials.118 Food business operators are to ensure that all stages of production, processing and distribution of food under their control satisfy the hygiene requirements set down in the regulation.119 This is to be ensured primarily through the use of what are known as the ‘hazard analysis and critical control points’ principles, or HACCP.120 The HACCP principles consist of: identifying hazards that must be prevented, eliminated or reduced to acceptable levels; identifying the critical control points at the steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels; establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; establishing and implementing effective monitoring procedures at critical control points; establishing corrective actions when monitoring indicates that a critical control point is not under control; establishing procedures that are to be carried out regularly to verify that the measures outlined above are working effectively; and establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined above.121 Evidence of compliance with these procedures must be supplied by food business operators to their national competent authorities.122 Member States are to encourage the development of national guides to good practice for hygiene and for the application of HACCP principles.123 Similar Community guides are also to be developed.124 The Commission is obliged to consult with EFSA on any matter falling 114 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety. [2002] OJ L 31/1. 115 Codex Alimentarius recommended International Code of Practice, General Principles of Food Hygiene. CAC/RCP 1/1969. Revised 2003. 116 Article 2(1). 117 Article 1(1). 118 Ibid. 119 Article 3. 120 Article 5(1). 121 Article 5(2). 122 Article 5(4). 123 Article 7. 124 Article 9.

(F) MacMaolin Ch5

9/2/07

15:16

Page 209

5.4 Community Food Safety Legislation 209 within the scope of the hygiene regulation that could have a significant impact on public health.125 The real detail on hygienic food production practices is set out in a series of annexes to the regulation. Annex I covers the general hygiene provisions for primary production, including requirements that animals going to slaughter are kept clean, and that staff handling foodstuffs are in good health and report suspected outbreaks of disease to the competent authorities. Annex II sets general hygiene requirements for all food business operators not covered by Annex I. Food premises are to be designed and constructed in a manner that permits adequate cleaning and provides adequate working space for the hygienic performance of all operations. Flush lavatories are to be available for staff, and they should not open directly into rooms in which food is handled. Washbasins are to be made available, suitably located and designated for washing hands. Cleaning agents and disinfectants are not to be stored in areas where food is handled. Additional requirements are set out for movable and temporary food premises, for premises normally used as a private dwelling house but where foods are regularly prepared for sale, and for vending machines. These must all, so far as is reasonably practical, be kept clean and maintained in good repair. In particular, facilities should be made available for the maintenance of personal hygiene, surfaces in contact with food should be in a sound condition and easy to clean, and there should be an adequate supply of clean water. Two further regulations on hygienic practices in the food sector have been introduced. These are Regulation 853/2004 on foods of animal origin,126 and Regulation 854/2004 on the organisation of official controls on products of animal origin.127 The idea behind introducing this body of regulations was to simplify and codify the existing rules set out in framework Directive 1993/43.128 Transportation Rules Directive 1998/28 grants derogations from certain provisions of the hygiene directive for the transportation by sea of bulk raw sugar.129 The derogation was granted as it was felt that the requirements in the predecessor to Regulation 852/2004, Directive 1993/43,130 on the transportation of bulk foodstuffs in liquid, granulate or powdered form in receptacles and/or containers/tankers reserved for the 125

Article 15. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. [2004] OJ L 139/55. 127 Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. [2004] OJ L 139/206. 128 Council Directive 1993/43/EEC of 14 June 1993 on the hygiene of foodstuffs. [1993] OJ L 175/1. 129 Commission Directive 1998/28/EC of 29 April 1998 granting a derogation from certain provisions of Directive 1993/43/EEC on the hygiene of foodstuffs as regards the transport by sea of bulk raw sugar. [1998] OJ L 140/10. 130 Council Directive 1993/43/EEC of 14 June 1993 on the hygiene of foodstuffs. [1993] OJ L 175/1. 126

(F) MacMaolin Ch5

9/2/07

15:16

Page 210

210 Food Safety in the EU transportation of foodstuffs was not practical and imposed an unduly onerous burden on food businesses when applied to the transportation of raw sugar by sea which is not intended for use as a food nor as a food ingredient without a full and effective refining process.131 Bulk transportation of raw sugar by sea can thus be done in receptacles and/or containers/tankers that are not exclusively used for the transportation of foodstuffs, provided that prior to loading the receptacle and/or container/tanker is cleaned to remove residues of the previous cargo, and provided that the immediate previous cargo was not a bulk liquid.132 Similar derogation is allowed for the transportation of bulk liquid oils and fats by sea.133 It was recognised that the availability of sea-going vessels reserved for the transportation of foodstuffs was insufficient to serve the trade in oils and fats intended for human consumption and that the contamination of liquid oils and fats could be avoided where the tanks used for their transportation are made of readily cleansable materials or where the three previous cargoes are of such a nature that they do not leave contamination and have been effectively cleaned.134 As a consequence, liquid oils or fats can be transported in tanks that are not exclusively reserved for the transportation of foodstuffs once certain conditions relating to the type of tank used, cleaning and previous cargoes are met.135 In particular, the three previous cargoes transported in the tank must have been foodstuffs where the oil or fats being transported are not to be processed further.136 Where there is to be further processing, only the previous cargo must have been a foodstuff or appear on a list of acceptable previous cargoes, listed in the Annex, including glycerine, acetic acid and sodium hydroxide. 5.5 FOOD ADDITIVES

One of the aspects of food production that attracts the most attention amongst consumers is the use of additives. Claims that a foodstuff ‘contains no artificial additives’ will often be one of the key determining factors for the health-conscious consumer. Additives also present an opportunity for producers who wish to obtain a certain flavour or colour for their product without necessarily incurring the expense, and possibly greater perishability, of more natural ingredients. As a result of the potentially controversial consequences of this aspect of food production, it has become clear that Community rules on additive use must be supported by more than a set of directives drafted in flexible terms. Clear, precise and concise rules on what gets added to food to preserve, thicken or colour it are also required. 131

Preamble to Directive 1998/28. Article 2. 133 Commission Directive 1996/3/ EC of 26 January 1996 granting a derogation from certain provisions of Council Directive 1993/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea. [1996] OJ L 21/42. 134 Preamble to Directive 1996/3. 135 Article 2. 136 Ibid. 132

(F) MacMaolin Ch5

9/2/07

15:16

Page 211

5.5 Food Additives 211 5.5.1 Additive Use Rules and Free Movement Member States seeking to preserve the quality of products traditionally made using natural ingredients can give rise to disputes under the terms of Article 28 EC. A series of cases have come before the Court of Justice on the interaction between Community additive legislation and free movement policy. In Commission v Italy, for example, the Court examined the compatibility of a national prohibition on the addition of nitrate to cheese with Community rules on additive use and Article 29 EC. Nitrate had been added to cheese for sale on the Italian market in quantities that were within the limits widely accepted in international scientific circles (50 mg per kg).137 The cheese in question was also lawfully manufactured and marketed in other Member States. Nitrate is added to various types of cheese in the course of their manufacture to help eliminate certain bacteria that make these products swell abnormally. It does, however, also exist naturally in many varieties of cheese, generally acting as a preservative. Italian law governing certain health aspects of the production and sale of food and drink provided that no chemical additives of any kind whatsoever could be used in the manufacture of foodstuffs and that no foodstuffs containing such additives could be made available for consumption without prior ministerial authorisation. No order pursuant to that law had authorised the use of nitrate in the production of cheese. Nitrate was at the time listed in the Annex to Council Directive 1964/54 as amended, the use of which could be authorised by the Member States.138 According to the Commission, the importation of foodstuffs manufactured in another Member State containing an additive included in the Community list had to be authorised provided that it posed no danger to public health and met a particular need. The Court noted that according to its own case law on the matter,139 rules making the use of an additive subject to authorisation complied with Community law if two conditions were satisfied. First, the rules had to make provision for a procedure that enabled traders to have the additive included on the national list of authorised additives. This procedure had to be one that was readily accessible and capable of being completed within a reasonable period and, if it led to a rejection, that rejection had to be open to challenge before the courts. Second, an application to have an additive included in the list in question could be rejected by the competent authorities only if the additive did not meet any genuine

137

Case C-95/1989, Commission v Italy (added nitrate) [1992] ECR I-4545. Council Directive 1964/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorised for use in foodstuffs intended for human consumption. [1964] OJ P 12/161. English Special Edition Series I, Chapter 1963–4, p 99. Directive 1964/54 was amended on 23 occasions. 139 Case 247/1984, Criminal proceedings against Léon Motte [1985] ECR 3887, para 25; Case 304/1984, Criminal proceedings against Claude Muller [1986] ECR 1511, para 26; Case C-42/1990, Criminal proceedings against Jean-Claude Bellon [1990] ECR I-4863, paras 16 and 17. 138

(F) MacMaolin Ch5

9/2/07

15:16

Page 212

212 Food Safety in the EU need, in particular a technological need. Even if it did meet such a need it must not present any danger to public health. The Court noted that it was not sufficient for the purpose of showing that an additive did not meet a genuine need to show that a product could have been manufactured using a different substance. Such an interpretation of the concept of need was seen to be capable of resulting in favouring national production methods over non-national ones, and thus able to constitute a disguised method of restricting trade between Member States. It was noted, however, that the Italian legislation on additives introduced a system comprising a ban, subject to the possibility of authorisation, that applied equally to additives in foodstuffs from Member States where they were lawfully manufactured and marketed and those of domestic origin. There could only be a breach of Article 28 EC if the additive authorisation procedure—compliance with the requirements of readily accessibility, efficiency and offering the possibility of appeal—unjustifiably rejected an application for the inclusion of a substance on the list of authorised additives. The procedure set up by the Italian legislation was not contrary to Community law and, as a result, the Commission’s action was dismissed. The Court will allow Member States to ban the use of additives in some circumstances, even where their use is permitted elsewhere in the Community. In Eyssen the Court examined the compatibility with Community law of a prohibition on the addition of nisin to cheese.140 Here, a Dutch manufacturer, who produced processed cheese for sale on the domestic market and for export to other Member States, was charged with having held in stock for the purpose of sale quantities of processed cheese containing added nisin. The addition of nisin to cheese was not permitted under Dutch law, although its use was permitted in other Member States. In view of this disparity between rules it was found to be indisputable that the prohibition by some Member States on the marketing within their territory of processed cheese containing additional nisin was of such a nature as to affect imports of that product from other Member States where, conversely, the addition of nisin was wholly or partially permitted. The Dutch rules thus constituted a measure having an effect equivalent to a quantitative restriction on imports. However, whilst a hindrance to Community trade was recognised, the prohibition and consequent restrictions on imports were justifiable under Article 30 of the EC Treaty on the ground of protecting human health. The domestic legislation at issue did not constitute a means of arbitrary discrimination, nor was it held to be a disguised restriction on trade between Member States. In Bellon,141 French rules prohibiting the importation and marketing of pastry to which sorbic acid had been added, from Italy, where its use was permitted, were examined. Sorbic acid use was also permitted in Community law under Directive 1964/54. In France it could only be used in a limited number of specified food140 Case 53/1980, Officier van Justitie v Koninklijke Kaasfabriek Eyssen BV [1981] ECR 409. For further discussion see S Weatherill, EU Consumer Law and Policy (Cheltenham, Edward Elgar, 2005), p 43. 141 Case C-42/1990, Criminal proceedings against Jean-Claude Bellon [1990] ECR I-4863, paras 16 and 17.

(F) MacMaolin Ch5

9/2/07

15:16

Page 213

5.5 Food Additives 213 stuffs. Since the products concerned were imported from another Member State, here they were lawfully produced and marketed, the application of the French rules was clearly to be regarded as a measure hindering intra-Community trade and thereby constituting, in principle at least, a measure having an effect equivalent to a quantitative restriction on imports. It therefore had to be ascertained whether or not this measure could be justified under Article 30 EC. The Court noted that any prohibitions on the marketing of products containing additives authorised in the Member State of production, but prohibited in the Member State of importation, had to be restricted to what was actually necessary to secure the protection of public health. It was found that the prohibition was justified on the grounds of public health protection but that, again, a system of approval for products such as those prohibited here must be implemented by Member States enforcing such a prohibition in order to ensure the legitimacy of the prohibition. In Grunert,142 criminal proceedings were brought against the defendant, the managing director of a company, for having offered for sale and then selling, knowing its intended destination, a product liable to adulterate foodstuffs for human consumption, in this case a preservative containing lactic acid and citric acid. The preservative in question was used in making pork-butcher’s meat and was marketed by the company managed by the accused. French law prohibited the addition to foodstuffs of any substance which had not previously been expressly authorised. Neither lactic acid nor citric acid had been so authorised and their use was therefore prohibited in the production of the foodstuff in question. The domestic court did note, however, that Directive 1964/54, and certain other directives,143 provided an exhaustive list of the preservatives authorised in the Member States and that this list included both lactic acid and citric acid. The Court was asked whether Member States are bound to authorise all the preservatives which may be used in foodstuffs that are listed in the additives directives, or whether they must merely prohibit the use of all those substances that are not included in those lists. The Court held that the directives require that Member States do not authorise the use in foodstuffs of preservatives or antioxidants which are not included in the lists annexed to the directives, but also that the Member States’ freedom to prohibit or to authorise the use of such substances must not have the effect of totally excluding the use in foodstuffs of any of the preservatives that are included in the lists, or of preventing all marketing of such a substance. In Motte,144 it was questioned whether a prohibition on the use of indigotin and cochineal, a red colourant, in the preparation of non-smoked fish roe was contrary to Community law. Criminal proceedings had been brought against the defendant for importing substances into Belgium that breached this prohibition, from 142

Case 88/1979, Criminal proceedings against Siegfried Grunert [1980] ECR 1827. In particular, Council Directive 1970/357/EEC of 13 July 1970 on the approximation of the laws of the Member States concerning the antioxidants authorised for use in foodstuffs intended for human consumption. [1970] OJ L 157/31. 144 Case 247/1984, Criminal proceedings against Léon Motte [1985] ECR 1329. 143

(F) MacMaolin Ch5

9/2/07

15:16

Page 214

214 Food Safety in the EU Germany, where they were authorised. The use of these colourants was authorised in Belgium for a number of other food types. National law prescribed that the addition of these colourants to specific foodstuffs required prior authorisation, such authorisation to appear in a positive list. It is clear that a national rule such as that at issue in this case is capable of contravening Article 28 EC given that the products imported are from another Member State where they are lawfully marketed. At the time of the case, only a small degree of harmonisation of the rules relating to the use of colourants in foodstuffs had been achieved. In the absence of harmonisation it is for the Member States to decide the extent to which national rules can be used to protect human health under Article 30 EC, but always taking account of Article 28 EC. The Court noted here that for those purposes Member States must take into account the results of international scientific research and, in particular, the work of the Community’s Scientific Committee for Food, the opinions of which do not have binding force. It was also noted that when examining whether an additive may be used in the preparation of a foodstuff the degree of harmfulness of this use is not to be the only consideration; the necessity of adding it to the foodstuff in question is also relevant. This need must be technological or economic, or as far as colouring or flavouring is concerned, organoleptic or psychological.145 It was thus held that Community law at the time did not preclude national provisions that required that the use of colourants, such as in this case, be entered on a national list drawn up after referral to a committee of experts. However, in applying such provisions to products imported from another Member State where they are lawfully marketed the national authorities must authorise the colouring of the foodstuff if it corresponds to a real need. In Muller,146 it was questioned whether Directive 1974/329147 prevented a Member State from prohibiting the use of one of the substances listed in the Annex to the directive.148 Citing Motte, the Court noted that the existence of harmonising directives did not exclude the operation of Article 28 of the EC Treaty and that it is only when Community rules make provision for the full harmonisation of all the measures needed to ensure the protection of health and institute Community procedures to monitor compliance therewith that recourse to Article 30 EC ceases to be justified. Consequently, when prohibitions on the use of additives specifically listed in Community legislation are applied to products imported from other Member States, Treaty provisions, namely Article 28 EC et seq, must be observed. It was thus held that Directive 1974/329 did not prevent a Member State from 145 Commission Recommendation 1980/1089/EEC of 11 November 1980 addressed to the Member States concerning tests relating to the safety evaluation of food additives. [1980] OJ L 320/36. 146 Case 304/1984, Criminal proceedings against Claude Muller [1986] ECR 1511. 147 Council Directive 1974/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs. [1974] OJ L 189/1. 148 Article 2(1) of Directive 1974/329 states that ‘Member States shall authorise the use as emulsifiers, stabilisers, thickeners and gelling agents in foodstuffs intended for human consumption, of only those substances listed in Annex I and where appropriate, only under the conditions specified therein’.

(F) MacMaolin Ch5

9/2/07

15:16

Page 215

5.5 Food Additives 215 prohibiting the use of one of the additives listed in the Annex, provided that free movement requirements were properly observed. The marketing of foodstuffs containing such substances must, however, be authorised, under a procedure easily accessible to manufacturers and traders, if the addition of the substance in question meets a genuine need and presents no danger to public health. It is for the national authorities to show in each case why domestic rules might be necessary to give effective protection to human health, or any of the other interests referred to in Article 30 of the EC Treaty. 5.5.2 Directive 1989/107 In order to reduce the potential for impediments to the free movement of goods, such as those in evidence in the preceding body of case law, harmonisation of the national rules was brought about by Directive 1989/107, which sets out Community-wide requirements for the use of additives in foodstuffs.149 The directive covers all additives, including colours, preservatives, antioxidants, emulsifiers, thickeners, gelling agents, stabilisers and flavour enhancers,150 which are used or which are intended to be used as ingredients during the manufacture or preparation of foodstuffs and which are still present in the final product, even if in altered form.151 Food additives are defined as being: any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.152

The directive does not apply to processing aids, flavourings or substances added to foodstuffs as nutrients, for example minerals or vitamins.153 In order for a food additive to be legally usable in the manufacture or preparation of foodstuffs it must be specifically listed as being usable and must only be used under the conditions specified,154 and in certain permitted foodstuffs.155 Additives can be added to or removed from the list of those permitted to be used depending on the circumstances if they either fulfil the requirements of the directive156 or if new 149 Council Directive 1989/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. [1989] OJ L 40/27. 150 Annex I to Directive 1989/107. 151 Article 1(1). 152 Article 1(2). 153 Article 1(3). The addition of vitamins and minerals to foodstuffs is now dealt with in new legislative proposals. See Proposal for a Regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods. COM (2003) 671. 154 Article 2(1). 155 Article 3(2)(b). 156 Article 5.

(F) MacMaolin Ch5

9/2/07

15:16

Page 216

216 Food Safety in the EU information shows that a previously approved additive is or may actually be dangerous to human health.157 The Scientific Committee for Food (now transferred to EFSA) must be consulted where the use of an additive may affect public health.158 Once approved, the Member States may not prohibit, or obstruct in any way, the marketing of food additives, food or food ingredients on grounds relating to food additives.159 The directive sets out a series of general criteria for the use of food additives.160 Food additives can only be approved if there can be demonstrated to be a reasonable technological need for their use and that purpose cannot be achieved by other means that are economically and technologically practicable. Additives may only be used where they present no known hazard to the health of the consumer at the level of use proposed and if their use does not mislead the consumer in any way. The use of food additives may be considered only where there is evidence that the proposed use of the additive would have demonstrable advantages of benefit to the consumer. The use of additives should serve one or more of specified purposes and only where these purposes cannot be achieved by other means which are economically and technologically practicable and do not present a hazard to the health of the consumer. These specified purposes include the preservation of the nutritional quality of the food, the provision of necessary ingredients or conditions for foods manufactured for groups of consumers having special dietary needs, the enhancement of food quality or organoleptic properties provided that this does not alter the nature or quality of the food to the extent that it might deceive the consumer, and the provision of aids to manufacturing, processing, preparation, treatment, packing, transportation or storage of food provided that the additive is not used to disguise the effects of the use of faulty raw materials or of undesirable, including unhygienic, practices or techniques during the course of any of these activities. Food additives are to be kept under continuous observation and re-evaluated whenever necessary to take account of changing conditions of use and any new scientific information. Any approval for the use of a food additive must specify the foodstuffs to which the additive may be added and the conditions under which it may be added. Additive use must always be limited to the lowest level of use necessary to achieve the desired effect, taking into account any acceptable daily intake, or equivalent assessment, established for the food additive in question and the probable daily intake of that additive from all sources.

157

Article 4. Article 6. 159 Article 12(2). 160 Annex II to Council Directive 1989/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. [1989] OJ L 40. 158

(F) MacMaolin Ch5

9/2/07

15:16

Page 217

5.5 Food Additives 217 5.5.3 Sweetener, Colour and Flavour Use In addition to the general legislation on additive use, there are also separate rules for the use of sweeteners161 and colours in foodstuffs.162 Directive 1994/35 lists those sweeteners which may be placed on the market for sale to the ultimate consumer or which may be used in the manufacture of foodstuffs.163 Sweeteners may not be used in foods for infants or young children unless specifically provided for.164 Directive 1994/36 sets similar requirements for the use of colours in foodstuffs. ‘Colours’ are defined as: substances which add or restore colour in a food, and include natural constituents of foodstuffs and natural sources which are normally not consumed as foodstuffs as such and not normally used as characteristic ingredients of food.165

Some substances, which are primarily added to the foodstuff for flavouring purposes, are not considered to be colours for the purposes of the directive, including paprika, turmeric and saffron, neither are colours that are used for the colouring of the inedible external parts of foodstuffs, such as cheese coatings and sausage casings.166 Only those substances listed in the directive are permitted to be used as colours in foodstuffs.167 Specific conditions for use are also set out in some circumstances.168 There is also specific provision in the directive for the launch of a campaign designed to inform consumers about the evaluation and authorisation procedures for permitted colours and the meaning of the ‘E’ number system.169 All Community legislation on food additives is based on the principle that only those additives that are explicitly authorised may be used. The use of food additives must always be labelled on the packaging of food products by their category, such as antioxidant, preservative or colour, with either their name or E-number.170 The official source for these numbers is the body of additive legislation with amendments where the additives are listed with their names and E numbers, normally in the Annex to the legislation.171 The numbering system is being adapted for international use by the Codex Alimentarius Commission, which is 161 European Parliament and Council Directive 1994/35/EC of 30 June 1994 on sweeteners for use in foodstuffs. [1994] OJ L 237/3 162 European Parliament and Council Directive 1994/36/EC of 30 June 1994 on colours for use in foodstuffs. [1994] OJ L 237/13 163 Article 2(1). Those sweeteners that may be used are set out in the Annex to Directive 1994/35. 164 Article 2(3). 165 Article 1(2). 166 Article 1(3). 167 Article 2(1). Substances permitted to be used as colours are listed in Annex I to Directive 1994/36. 168 Article 2. These substances are listed in Annex II, III, IV, and V to Directive 1994/36. 169 Article 8 of Council Directive 1989/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. [1989] OJ L 40/27. 170 Ibid. 171 See, for example, Annex V to European Parliament and Council Directive 1994/36/EC of 30 June 1994 on colours for use in foodstuffs. [1994] OJ L 237/13.

(F) MacMaolin Ch5

9/2/07

15:16

Page 218

218 Food Safety in the EU developing a system that largely uses the same numbers but without the ‘E’, used to indicate EU approval.172 Additional requirements have been created for food additives other than colours and sweeteners by Directive 1995/2,173 including preservatives, antioxidants, acidity regulators, anti-caking agents and flavour enhancers. Only those substances specifically listed in the directive are permitted to be used for their stated purposes in the manufacture of foodstuffs,174 with separate additional requirements for foods for infants and young children.175 The use of flavourings in foodstuffs, which are not covered by the additive legislation, are controlled by Directive 1988/388.176 Again, the differences between the national laws of the Member States relating to flavourings, which were deemed to be hindering the free movement of foodstuffs and creating unequal competition conditions, were cited as one of the primary reasons for the adoption of this harmonising legislation.177 ‘Flavourings’ are defined in the directive as ‘flavouring substances, flavouring preparations, process flavourings, smoke flavourings or mixtures thereof’.178 Flavouring substances are: a defined chemical substance with flavouring properties which is obtained by appropriate [physical or chemical] processes . . . from material of vegetable or animal origin either in the raw state or after processing for human consumption by traditional foodpreparation processes [or] by chemical synthesis [which] is not chemically identical to a substance naturally present in material of vegetable or animal origin.179

A flavouring preparation is: a product, other than [flavouring substances] whether concentrated or not, with flavouring properties, which is obtained by appropriate physical processes (including distillation and solvent extraction) or by enzymatic or microbiological processes from material of vegetable or animal origin, either in the raw state or after processing for human consumption by traditional food-preparation processes (including drying, torrefaction and fermentation).180

The word ‘natural’, or any other word having substantially the same meaning, may only be used for flavourings in which the flavouring component contains exclusively flavouring preparations.181 They are produced from material of vegetable or animal origin. 172

List of Codex Advisory Specifications for Food Additives. CAC/MISC 6/2001. European Parliament and Council Directive No 1995/2/EC of 20 February 1995 on food additives other than colours and sweeteners. [1995] OJ L 6195. 174 Article 2(1). 175 Article 2(3)(b). Those products covered by the Directive that are permitted for use in the manufacture of foodstuffs are listed in the Annex to European Parliament and Council Directive No 1995/2/EC of 20 February 1995 on food additives other than colours and sweeteners. [1995] OJ L 61. 176 Council Directive 1988/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production. [1988] OJ L 184/61. 177 Preamble to Directive 1988/388. 178 Article 1(2). 179 Ibid. 180 Ibid. 181 Article 9(2). 173

(F) MacMaolin Ch5

9/2/07

15:16

Page 219

5.6 Conclusion 219 Member States are to take all measures necessary to ensure that flavourings do not contain any element or substance in a toxicologically dangerous quantity, that the use of flavourings does not result in the presence in foodstuffs of undesirable substances listed in the directive, and that the use of flavourings and other food ingredients with flavouring properties does not result in the presence of certain substances in quantities greater than those specified in the legislation.182 Procedures for ensuring that the use of flavourings does not harm human health are set out in the directive.183 The directive applies to flavourings intended for use in foodstuffs imported into the Community but does not apply to those destined for export outside the Community.184 5.6 CONCLUSION

The BSE crisis marked a watershed in the development of EU food law. The aims of devising and implementing rules on the production and marketing of food have been prioritised once more. The emphasis is now firmly on safety. This has resulted in the unprecedented creation of a food safety authority, which must be consulted on a broad range of policy matters, from labelling to crisis management. Existing measures, such as those on the hygienic production and marketing of food, have been reassessed, simplified and consolidated in an attempt to make them more user friendly, and ultimately to improve compliance rates. The single most profound change to the manner in which EU food law now operates is that the institutions are empowered, due to acceptance of the precautionary principle, to pre-empt and act upon any dangers that may exist in the food supply chain. Once supported by a level of scientific evidence justifying their action, the use of certain products or procedures may be suspended where there is cause for concern about their safety. Member States, through use of the safeguard clauses that are inserted into much of the Community’s secondary legislation, may also act contrary to free movement rules where they have reason to suspect that there may be an imminent danger to human health.185 This new-found flexibility should go some way to protecting consumers from unsafe food making it onto the market. While this liberal (and initially erroneous) interpretation of Treaty provisions is a welcome development, Member States do however remain paralysed as regards the extent to which they can intervene domestically in order to counter the fact that diets are becoming increasingly dangerous throughout the EU, resulting in very serious health concerns for a large proportion of its citizens.

182 Article 4. The substances and quantities referred to are listed in Annex I and Annex II to Directive 1988/388. 183 Articles 6, 7 and 8. 184 Article 11. 185 For further discussion on the availability of these safeguard clauses to the Member States see G Berends and I Carreño, ‘Safeguards in Food Law—Ensuring Food Scares are Scarce’ (2005) 30 European Law Review 386.

(F) MacMaolin Ch5

9/2/07

15:16

Page 220

(G) MacMaolin Ch6

9/2/07

15:17

Page 221

6 Nutrition Law and Policy in the EU 6.1 INTRODUCTION

T

HE PREPONDERANCE OF the body of food law that has been initiated and developed by the Community institutions, in particular the Court and the Commission, has focused on two main areas: food safety and free movement. This could be extended to include health protection and consumer protection. However, we have seen in previous chapters that these two concerns fall well down the rankings in the Community’s order of priorities. In particular, it has become clear that Member States lack autonomy in the introduction of national measures that could be used to promote health or consumer protection, despite the existence of Article 30 EC and the development of the mandatory requirement exception by the Court of Justice. This makes it very difficult for the Member States to introduce their own health promotion measures where these may inhibit free movement in any way. Given the manner in which EU food law has developed, Member States have become over-reliant on the Community as the principal source of new food laws. This, of course, should not necessarily present a problem in itself. However, potential difficulties do arise when the Community is also unwilling to take the necessary measures that could assist the Member States in ensuring, as far as possible, that society is well-fed and, most importantly, well-nourished. The Commission has to date failed to oblige in this regard. By focusing its energies on safety and free movement, the issue of the nutritional value of food consumed in the European Union has always been of secondary priority. European Community food law could be described as being safe and comfortable, and often not that useful. There are rules to determine the hand-washing facilities that must be available in areas where food is prepared.1 There are rules in place determining that prepackaged foodstuffs must display a best before or use by date.2 There are rules specifying the minimum age at which animals can be

1 Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. [2004] OJ L 139/1. 2 Articles 3(1) and 10 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29.

(G) MacMaolin Ch6

9/2/07

15:17

Page 222

222 Nutrition Law and Policy in the EU slaughtered in order to be considered ‘organic’.3 However, there are no controls in place to ensure that the person preparing food does wash his or her hands. There are no controls over the producer’s choice of ‘best before’. There are no controls that can reasonably prevent the slaughtered animal being carved up on the same surface as meat already cooked, maybe by the same, unsterilised, knife. The claims made here about the negligent focus of European food law on the ‘wrong issues’ is exemplified by the Commission document Healthy Food for Europe’s Citizens: The European Union and Food Quality.4 One might expect that a document so titled would contain information and discussion about Community efforts to increase the nutritional value of food, to maintain food quality levels, and to reduce intakes of salt, sugar and unnecessary fat, especially amongst the young and the vulnerable. Not so. Instead, Healthy Food for Europe’s Citizens commences by outlining why food safety and quality levels are a concern, stating that ‘consumers are demanding the highest possible standards from farmers, food companies and retailers’. This is simply untrue. It may be correct to say that some consumers have reverted to purchasing some of their food from local, possibly reliable, and traceable sources. The vast majority do not do so. They continue to overload their supermarket trolleys with products from untraceable sources, made from poor quality ingredients and which may contain meat from a processing plant that does not maintain minimum hygiene standards, or which has not been reared to acceptable animal welfare standards. Some are oblivious to this. Some are apathetic. If food tastes fine, and most importantly if it is cheap, then the majority of consumers are not particularly interested in ‘demanding the highest possible standards from farmers, food companies and retailers’. Such an assertion can only be said to be true if ‘the highest possible standards’ means that consumers insist upon food that has not gone off, or tastes as if it has not gone off. It does not extend to insisting that juice for children does not make them hyperactive, nor that the ingredients in crisps contribute to making them overweight and improperly nourished. The EU institutions, and many of the Member States, have incorrectly defined both ‘food quality’ and ‘food safety’, rendering them, to a large extent, meaningless terms. While it is noted that ‘addressing consumers’ safety concerns and quality expectations is a major responsibility for the European Union’, this is something that has never been seen through properly. It is stated that ‘over the last 40 years, the EU has developed a comprehensive set of rules, standards and monitoring practices to guarantee that the food we eat is as safe and appetising as possible’.5 It is here contended that EU food law has actually led to a depreciation in the nutritional value of food, or at the very least removed the possibilities for Member States to ensure that food marketed on their territory is of the highest 3 Annex to Council Regulation (EC) No 1804/1999 of 19 July 1999 supplementing Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs to include livestock production. [1999] OJ L 222/1. 4 European Commission Directorate General for Education and Culture (2000) ISBN 92-828-8238-1. 5 Ibid.

(G) MacMaolin Ch6

9/2/07

15:17

Page 223

6.1 Introduction 223 nutritional standard, quite aside from the fact that the rules described are reactive rather than proactive in nature. However, where it is said here that the terms ‘food safety’ and ‘food quality’ have not been properly defined, this is primarily due to the fact that nutritional value has remained for the most part outside the factors that are taken into account in determining what qualifies as safe or high quality food. The European Union needs to refocus these definitions to include nutrition, not as a possible by-product of safety and/or quality initiatives, but as an integral part of any determination on just what constitutes safe or quality food in order to ensure that the majority of consumers are protected not only from unscrupulous business practice, but also, and perhaps more importantly, from themselves. The Commission, through both its documentation and its actions, has combined food safety and food quality into one overarching category of concern. It is also deemed to be the primary function of Community food law and policy to ensure that food products are of a high quality and that they are safe. But what do these terms really mean? It is clear that the Commission is of the opinion that by ensuring safety it provides quality, and vice-versa. It is not in dispute that there is some overlap between the two issues, but they are more clearly distinguishable than has been presumed to date. The EU intervenes in the food production process in several ways to ensure safety and quality—the much heralded ‘farm to factory to fork’ approach. The Common Agricultural Policy is the chief mechanism that can be used to maintain or increase food quality levels. The Commission claims that by reducing price support levels farmers are given a greater incentive to produce higher quality foodstuffs in order to secure a higher price on the market. While there is some evidence to suggest an increase in consumer demand for higher quality agricultural products, this generally obtains only amongst the more affluent sections of society. In addition to this, pressure exerted by supermarkets leads to reduced prices being paid to the farmer, who is already without the previous high levels of price support. For his business to survive, something has to give. The competitive farmer placed in such a position can respond in one of two ways. Either their agricultural practices have to become more intensive to reduce unit costs, or quality has to be compromised to reduce overall costs, consequently compromising both quality and safety. There is little dispute about the fact that the very public scares over the safety of food in the 1990s pushed the issue to the top of consumers’ list of priorities.6 Responses to such scares will always be at their most intense in the immediate aftermath of any such crisis. Soon after, when the media has shifted its focus to a different story, consumers may claim that safety remains their key concern, but in reality price, and to a lesser extent taste, will be the main determinants in any purchasing choice. This takes the pressure off the legislator, which can be left to establish a crisis response process. It is highly questionable whether any legislative

6

See, for example, Eurobarometer 238 on Risk Issues, February 2006.

(G) MacMaolin Ch6

9/2/07

15:17

Page 224

224 Nutrition Law and Policy in the EU initiatives taken in this regard can ever achieve the full desired effect. Complementary to this will be a series of legislative measures designed to minimise the potential for such a scare to occur again. This will generally be the body of legislation that existed at the time of the outbreak of the previous scare, or a modified version of it. From the 1970s onwards, the European Community has introduced measures contributing to this body of rules on matters such as veterinary controls, pesticide use and the spread of pathogens. The Commission sees this as one of two aspects of ensuring food quality, the other being satisfaction of consumer expectations of subjective criteria, such as taste. It is here accepted that food quality does indeed have two aspects to it, but the first one is not related to veterinary controls, pesticide use and the spread of pathogens—these are all specifically food safety issues. The first element of quality is actually nutritional value, yet this is not adequately recognised at Community level. To summarise, quality relates to nutritional value and subjective criteria, such as taste, appearance and smell; the organoleptic properties. Food safety concerns harmful effects on human health. This can be distinguished from nutritional value because the intake of a portion of non-nutritious food will not have any medium- to long-term effect on human health as such, but the consumption of an unsafe food due to, for example, the presence of a pathogen or harmful substance, has the potential to damage health, possibly even to kill. As a consequence of this misinterpretation of the extent to which the Community is responsible for the protection of human health through the consumption of safe or quality food, the issue of nutrition has become sidelined, when in fact it should be the key component of any food quality programme. Nutrition and physical activity are key determinants for the prevalence of obesity, which continues to rise in the EU among children and adults. Despite this, the Community remains unwilling to intervene. European Union food laws actually make it easier to market a food product that is high in fat, sugar or salt as being of nutritional value than a food with added vitamins and/or minerals that is low in unnecessary fat, sugar or added salt. Attempts to at least partially alter this have been made with the proposal for authorising nutritional and health claims. However, as demonstrated below, the procedure used to turn this proposal into a regulation has led to one of the key factors protecting consumers from nonnutritious food being altered to the extent that such claims will now be capable of being made on the labelling of ‘unhealthy’ foodstuffs. While the issue of nutrition specifically did not come within the ambit of the White Paper on Food Safety, it was recognised therein that the future direction of European Community food law should, among other things, aim at ensuring the intake of essential nutrients while limiting intake of other elements in order to avoid adverse health effects, including anti-nutritional effects. Nutritional information should thus be made clear and accessible to the consumer. Measures would be taken to establish the conditions for making claims such as ‘low sodium’ or ‘gluten free’. It was also proposed that two directives would be introduced, on food supplements and fortified foods. An overall comprehensive and coherent nutritional policy was to be devised.

(G) MacMaolin Ch6

9/2/07

15:17

Page 225

6.2 Community Legislation on Nutrition 225 It is this policy and the results it has achieved that is assessed below through an examination of existing nutrition labelling rules, new legislation on nutrition and health claims, food supplements controls and, perhaps most importantly, the manner in which EU food law prevents Member States from introducing their own legislative initiatives to help combat nutrition-related health issues—in particular rising rates of obesity. 6.2 COMMUNITY LEGISLATION ON NUTRITION

6.2.1 Nutrition Labelling Directive 1990/496 lays down Community requirements for nutrition labelling on foodstuffs.7 ‘Nutrition labelling’, for the purposes of the directive, means any information appearing on the labelling relating to energy values and nutrients such as protein, carbohydrates, fat, fibre, sodium and certain vitamins and minerals.8 Nutrition labelling is only compulsory where there is a nutrition claim on the labelling, in the presentation or in the advertising of the food.9 In all other cases, the placing of nutrition labelling information on the foodstuff is optional.10 A ‘nutrition claim’ is defined as: any representation and any advertising message which states, suggests or implies has particular nutrition properties due to the energy (calorific value) it [either] provides, provides at a reduced or increased rate or does not provide and/or due to the nutrients it [either] contains, contains in reduced or increased proportions or does not contain.11

Nutrition labelling must appear in one of two set forms. It should either detail the energy value and the amounts of protein, carbohydrate and fat present in the foodstuff, or it may display this information and additional details relating to the amounts of sugars, saturates, fibre and sodium contained in the product.12 Nutrition labelling may also include the amounts of one or more of starch, polyols, monounsaturates, polyunsaturates, cholesterol or any of the minerals or vitamins listed in the Annex to the directive (such as Vitamins A, C, D and E and minerals calcium, phosphorus, iron and zinc), if present in significant amounts (usually 15% of the recommended daily allowance per 100 g or 100 ml or per single portion).13 The directive also sets out the requirements for how all this information is to be displayed on the label, for example, the manner in which the energy value is to be calculated and then declared.14 All the nutrition information 7 Council Directive 1990/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs. [1990] OJ L 276/40. 8 Article 1(4)(a). 9 Article 2(2). 10 Article 2(1). 11 Article 1(4)(b). 12 Article 4(1). 13 Article 4(3). 14 Articles 5 and 6.

(G) MacMaolin Ch6

9/2/07

15:17

Page 226

226 Nutrition Law and Policy in the EU covered by the terms of the directive is to be presented together in one place, in legible and indelible characters in a conspicuous place, in a language easily understood by purchasers, and in tabular form, unless space on the label does not allow. In such circumstances, the information may appear in linear form.15 Member States may not lay down requirements that are more detailed than those contained in the directive.16 6.2.2 Nutrition and Health Claims One of the most interesting, complex and widely debated legislative initiatives to come from the Commission in recent years is the proposal for a new regulation on nutrition and health claims. An examination of this regulation illustrates three key points about the nature of EU food law more generally. First, it is quite clear that increasing attention has been paid to consumer concerns and protection in recent years. This has already been demonstrated in Chapter 2 in relation to the manner in which the Court of Justice now more readily accepts, in some circumstances, Member States’ justifications for the maintenance of national laws that are seemingly at odds with Community free movement rules. The regulation on nutrition and health claims presents another example of this. Some producers make unclear and unsubstantiated claims about the beneficial properties of their products. Now, in light of refocused attention on regaining consumer confidence in the food sector, any such claims made in the future will have to be verified prior to marketing. Second, while this new approach to consumer and health matters is a welcome development, albeit one that required a series of food safety crises prior to its initiation, the promotion of the free movement of food throughout the internal market remains the number one priority of the EU legislator. It was only when a threat to the uninhibited movement of foodstuffs bearing health claims surfaced that the proposal to introduce this regulation appeared. Finally, despite the intentions of those responsible for drafting this new legislation, the legislative process— here the Article 251 EC procedure involving full parliamentary consultation—has led to one of the most important aspects of the regulation being altered to such a degree that the original plan to prevent unhealthy foodstuffs from bearing nutrition or health claims has been overruled. Now, as a result of the amendments that have taken place during this procedure, foods that are high, even very high, in substances that may have detrimental effects on human health can bear claims that they are, in fact, healthy. Background to the Regulation on Nutrition and Health Claims The proposal for a regulation on nutrition and health claims was first introduced in July 2003, and was accepted by all parties to the Article 251 EC procedure in 15 16

Article 7(1) and (2). Article 7(3).

(G) MacMaolin Ch6

9/2/07

15:17

Page 227

6.2 Community Legislation on Nutrition 227 May 2006.17 It followed the decision of the Court in Austria v Commission, where it was held that the terms of the framework food labelling directive prohibited all health claims relating to human diseases.18 Article 2(1)(b) of Directive 2000/13 provides: The labelling and methods used must not . . . attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties.

When examining whether Austrian national law prohibiting claims made in respect of foods that referred to the prevention, relief or cure of illnesses was compatible with Articles 28–30 EC, the Court stated: Article 2(1)(b) of Directive 79/112 [now Directive 2000/13] only allows the Member States to prohibit statements relating to diseases. It leaves room, however, for healthrelated information on the labelling of foodstuffs, subject to compliance with the other conditions laid down by that directive, in particular the condition that such information must not mislead the purchaser.19

The Commission’s proposal for a regulation on nutrition and health claims noted how technological innovation in the food sector would make it possible for foods to possess health benefits, in particular disease prevention, in the future. The interpretation of the framework food labelling directive by the Court in Commission v Austria would prevent these new foodstuffs from being marketed effectively, making claims that consumers would want to know about and which they would not be misled by. It was therefore deemed necessary to make it possible for such claims to be made, provided they were supported by scientific verification that such beneficial properties could be gained from consuming the products concerned. In addition to this, fears about the consequences for free movement due to fact that some Member States had adopted their own legislation on these types of claims added to the sense of necessity for bringing in new Community-wide legislation in this area. The impetus to develop EU rules on nutrition and health claims was furthered by the fact that similar guidelines had already come into existence at international level. As noted in Chapter 4, it can be important to keep EU rules similar to international standards in order to minimise the possibility of disputes arising in the WTO. As noted earlier, Codex Alimentarius guidelines exist for claims generally,20 and for nutrition and health claims more specifically.21 Initially, the latter dealt with nutrition claims only. Guidelines for health claims were added in the 2004 review. The definitions and general principles of the Codex guidelines are almost identical to the new EU standards. However, the EU regulation goes into far more 17 Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods. COM (2003) 424. 18 Case C-221/2000, Commission v Austria (health claims) [2003] ECR I-1007. 19 Paragraph 16. 20 Codex General Guidelines on Claims. Codex Guidelines 1/1979. Revised 1991. 21 Codex Guidelines for Use of Nutrition and Health Claims. Codex Guidelines 23/1997. Revised 2004.

(G) MacMaolin Ch6

9/2/07

15:17

Page 228

228 Nutrition Law and Policy in the EU detail on what can constitute a legitimate claim and, in particular, the types of procedure involved in substantiating claims made. Key Provisions of Nutrition and Health Claims Legislation Any claim that is made that does not comply with the terms of the regulation is deemed to be misleading advertising within the meaning of Directive 1984/450.22 Nutrition claims are defined as being: any claim which states, suggests or implies that a food has particular nutritional properties due to: (a) the energy (calorific value) it provides, provides at a reduced or increased rate, or does not provide and/or (b) the nutrients or other substances it contains, contains in reduced or increased proportions, or does not contain.

Essentially, therefore, a nutrition claim is any representation that a foodstuff has increased or reduced energy levels or increased or reduced nutrient levels. A representation is not limited to the labelling of the product. It can include any ‘pictorial, graphic or symbolic representation, which states, suggests or implies that a food has particular characteristics’, thus including the label, packaging, advertising and manner in which the product is displayed for sale. Nutrients include protein, carbohydrate, fat, fibre, sodium, vitamins and minerals as listed in the Annex to Directive 1990/496.23 Health claims are defined as being: any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.

Finally, reduction of disease risk claims are: any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.

No nutrition and health claims made can be false or misleading in any way. They may not raise any doubts about the safety and/or nutritional adequacy of other foods. Most importantly, no claim should ever state or imply that it is untrue that a balanced and varied diet does not provide appropriate quantities of nutrients. The most controversial aspect of the regulation is that it provides for the establishment by the Commission of what are called ‘nutrient profiles’ which must be adhered to before a nutrition or health claim can be legitimately made. These profiles establish maximum levels for fats, including saturated fatty acids and trans fatty acids, sugars and salt that can be present in any foodstuff where a nutrition or health claim is made. The profiles are to be based on scientific knowledge about diet, nutrition and their relationship to health, and, in particular, on the role of nutrients and other substances with a nutritional or physiological effect on 22 Council Directive 1984/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising. [1984] OJ L 250/17. 23 Council Directive 1990/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs. [1990] OJ L 276/40.

(G) MacMaolin Ch6

9/2/07

15:17

Page 229

6.2 Community Legislation on Nutrition 229 chronic diseases. Profiling is to take place after consultation with the European Food Safety Authority (EFSA) and interested parties, in particular food business operators and consumer groups. The original proposal for the regulation stipulated that no aspect of these profiles could be exceeded if a nutritional or health claim was to be legitimately made. However, during the legislative process, Parliament insisted that this be amended. As a result, producers may breach one element of this profile and still make a nutrition or health claim. This essentially means that a foodstuff may carry such a claim even where the product in question is high (or even very high) in fats, sugars or salt. Alcoholic drinks must not carry health claims, or nutrition claims, except where these refer to the fact that the product contains a reduced alcohol or calorific content. Generally, nutrition and health claims can only be made if the presence, absence or reduced content of the substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by accepted scientific data. The substance for which the claim is made must be in a form that can be used properly by the body. These claims can only be made where the ‘average consumer’ as defined by EU law can be expected to understand the beneficial effects expressed. Central to the regulation is the fact that in future all health and nutrition claims will only be capable of being made where there is clear scientific evidence supporting the fact that the food possesses beneficial properties. All products carrying such claims must also bear information on the labelling relating to energy, protein, carbohydrate and fat levels. For health claims, the level of information to be provided is that as set out in Group 2 of Article 4(1) of the nutrition labelling directive, namely details of the energy value and protein, carbohydrate, sugar, fat, saturate, fibre and sodium levels. Full details of the quantity of any substance that relates to the nutrition or health claim must also be disclosed where it is not automatically provided by the general nutrition labelling requirement. Examples of the type of nutrition claims that may be used, and the criteria that must be satisfied for this use to be legitimate, are set out in the Annex to the regulation. They are practically identical to those set out in the Codex Alimentarius Guidelines for Use of Nutrition and Health Claims. These include: low fat, which may only be made where the product contains no more than 3 g of fat per 100 g or 1.5 g of fat per 100 ml; fat free, which may only be used where the product contains no more than 0.5 g of fat per 100 g or 100 ml—claims expressed as ‘X% fat-free’ are now prohibited; sugar free, which may only be used where the product contains no more than 0.5 g of sugar per 100 g or 100 ml; low sodium/salt, which may only be used where the product contains no more than 0.12 g of sodium per 100 g or 100 ml; source of fibre, which may only be made where the product contains at least 3 g of fibre per 100 g of 1.5 g of fibre per 100 kcal; and natural source of vitamins and/or minerals, which may only be made where the product contains a significant amount of the vitamin or mineral listed, usually at least 15% of the recommended daily allowance, as set out in the Annex to Directive 1990/496.24 24

Ibid.

(G) MacMaolin Ch6

9/2/07

15:17

Page 230

230 Nutrition Law and Policy in the EU Twenty-four such categories of nutrition claims are set out in similar terms in the Annex. The regulation will also apply to trademarks. Existing brand names suggesting health benefits, such as weight loss, that do not satisfy the terms of the regulation will not be permitted for use within 15 years of its entry into operation. Existing nutrition claims may continue to be made for two years, and health claims for three years, even where they do not comply with the regulation’s requirements. A series of additional requirements for health claims are set out in the regulation. These include the fact that there must be a statement on the product indicating the importance of a balanced diet and a healthy lifestyle. The quantity of the food and pattern of consumption required to obtain the benefits promoted must also be stated, as should warnings about possible risks of over-consumption and warnings for those who should avoid consuming the product at all. Implied health claims that make reference to general, non-specific benefits, or which refer to psychological benefits, are not permitted. The regulation on nutrition and health claims has been criticised for potentially putting small operators to great expense in order to be able to produce the data necessary to substantiate claims that they may wish to make about their food products. This need not be the case. Health claims describing the role of a nutrient in growth, development and normal bodily functions, which are based on generally accepted scientific data and well understood by the average consumer, may be made by all operators if they have been included in the positive list of such claims. Member States must provide the Commission with claims that they want included in this list. The Commission and EFSA will consider such requests. It should also be noted that the types of claim considered by the Court in Commission v Austria, namely claims relating to disease, are specifically permitted by the regulation where they are authorised in the same manner as other health claims. Authorisation Procedure Authorisation must be granted at EU level before a health claim can be used in the marketing of a food product. Applications are made to EFSA, which must inform the Member States and the Commission of this. The application is to include: the applicant’s details; details about the food for which a claim is to be made; copies of studies that have been carried out which demonstrate that the claims being made are verifiable and beneficial—these studies should be independent and peerreviewed; copies of other scientific studies relevant to the claim; a proposal for the wording, in all Community languages, of the health claim for which authorisation is sought including, where relevant, any specific conditions for use of the food; and a summary of the dossier presented in support of the application. This summary is also to be made available to the public. Once the application has been received, EFSA must give an opinion on it within three months. Additional information may be requested from the applicant. The key role of the Authority at this stage is to verify that the proposed wording of the health claim is substantiated by the scientific data, that it complies with the

(G) MacMaolin Ch6

9/2/07

15:17

Page 231

6.2 Community Legislation on Nutrition 231 criteria laid down in the regulation, for example that a recognisable health benefit must accrue from consuming the product, and that the claim is understandable and meaningful to the average consumer. The Authority forwards its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and reasons for arriving at its opinion. The Authority is also obliged, under the terms of Regulation 178/2002, to make its opinion known to the public, who then have 30 days to submit comments.25 The Authority does not authorise the use of health claims. It gives an opinion on compliance with the terms of the regulation. The ultimate decision on the use of a health claim rests with the Commission, which takes the opinion of the Authority into account in reaching its decision. The Commission then informs the Standing Committee on the Food Chain and Animal Health, explaining any deviation from the earlier opinion of EFSA where appropriate.26 The applicant is then informed of the decision taken. This is also published in the Official Journal of the European Union. Granting authorisation does not lessen the civil or criminal liability of food operators in respect of the permitted food in any way. Authorisations may be modified, at the request of the holder, or suspended or revoked in certain circumstances. EFSA can investigate whether an authorisation to use a health claim continues to meet the conditions required. These investigations can take place on the Authority’s own initiative or following a request from a Member State or the Commission. Again, the Authority furnishes the Commission with an opinion. It is the Commission which then decides whether the authorisation previously granted should be modified, suspended or revoked. Where Member States have sufficient grounds for considering that a claim does not comply with the terms of the regulation, or that the level of scientific substantiation provided is insufficient, they may temporarily suspend the use of that claim within their territory. Such a Member State must inform the other Member States and the Commission of this, outlining the reasons for its action. Where this happens, it is up to the Authority to form an opinion on this suspension, which it provides to the Commission, which in turn decides whether this can stand. The suspension may be maintained by the Member State until any such decision has been reached. Finally, the Commission must establish and maintain a publicly available Community register of nutrition and health claims made in relation to food. This register must include details of both authorised nutrition and health claims and rejected health claims. Member States may require that the manufacturers of products carrying nutrition or health claims notify them prior to placing these 25 Article 38(1) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. [2002] OJ L 31/1. 26 In accordance with the procedure set out in Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. [1999] OJ L 184/23.

(G) MacMaolin Ch6

9/2/07

15:17

Page 232

232 Nutrition Law and Policy in the EU foodstuffs on their domestic market. In such circumstances, a model of the label to be used should be sent to the competent authorities of the Member State in question.

6.2.3 Food Supplements Scientific evidence makes it clear that a healthy and balanced diet should provide all the nutrients that are necessary to promote human health. Despite this, many people take nutrient supplements to counter dietary deficiencies. Directive 2002/46 lays down Community rules governing the production and marketing of these food supplements.27 The legislation is necessary for several reasons: obviously there are the usual reasons relating to the internal market, in particular harmonising the different rules of the individual Member States to ensure, as far as possible, the free movement of the goods at issue. In addition to such reasons, it is important to ensure that there is official control over these food supplements because they may pose a danger to human health, in particular if they are taken in excessive amounts. As a consequence, the maximum amount of nutrient that can be present in any supplement must be controlled.28 Similarly, if a consumer is purchasing these products to supplement nutrient intake from their diet, minimum levels of nutrient must also be set to ensure that the consumer gains the expected benefits.29 The general labelling provisions of the framework food labelling directive, Directive 2000/13,30 are applicable to food supplements, but some additional requirements are also set. The labelling, presentation and advertising cannot attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.31 The labelling must bear information relating to the names of the categories or substances that characterise the product, the portion of the product recommended for daily consumption, a warning not to exceed the stated recommended daily dose, a statement to the effect that food supplements should not be used as a substitute for a varied diet, and a statement to the effect that these products should be stored out of the reach of young children.32 There must be no statement on the labelling implying in any way that appropriate quantities of nutrients may not be obtained through a balanced and varied diet.33

27 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. [2002] OJ L 183/51. 28 Article 5(1) and (2). 29 Article 5(3). 30 For the purposes of Article 5(1) of Directive 2000/13, products covered by Directive 2002/46 are to be labelled ‘food supplement’. Article 6(1) of Directive 2002/46. 31 Article 6(2) of Directive 2002/46. 32 Article 6. 33 Article 7.

(G) MacMaolin Ch6

9/2/07

15:17

Page 233

6.2 Community Legislation on Nutrition 233 ‘Food supplements’ are defined in the directive as being: foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect [marketed in] forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar . . . measured small unit quantities.34

Nutrients, for the purposes of the directive, include vitamins and minerals.35 Only those vitamins and minerals listed in Annex I to the directive (for example vitamin C, folic acid, iron) may be used as food supplements.36 Member States may continue to permit the use of vitamins and minerals not listed in Annex I until the end of 2009, provided that the substance in question was already in use in this way in the Community on the date of the entry into force of the directive, and provided that EFSA has not given an unfavourable opinion on the use of this substance.37 Information on vitamins and minerals appearing on the labelling of food supplements should be expressed as a percentage of the reference values mentioned in the Annex to Directive 1990/496.38 While Member States may not prohibit or restrict trade in products that comply with the terms of the directive, provision is made for resort to Article 30 EC where national rules restrict trade in supplements that are not regulated under this directive or any acts adopted pursuant to it.39 Where a Member State has reason to believe, due to either new information or a reassessment of existing information, that a food supplement poses a danger to human health, even though it complies with the terms of the directive, it may temporarily suspend or restrict its use. It must inform the Commission and the Member States of any action taken in this regard, giving reasons for its decision. The Commission must then examine this new information, assisted by the Standing Committee on the Food Chain and Animal Health, and take appropriate measures on the basis of its findings. Where necessary, the Decision 1999/468 procedure is to be invoked.40 Any provisions whatsoever that may have an effect on public health are to be adopted under the terms of this directive after consultation with EFSA.41

34 35 36 37 38 39 40 41

Article 2(a). Article 2(b). Article 4(1). Article 4(6). Article 8(3). Article 11. Articles 12 and 13. Article 14.

(G) MacMaolin Ch6

9/2/07

15:17

Page 234

234 Nutrition Law and Policy in the EU

6.3 NUTRITION POLICY AND FREE MOVEMENT

6.3.1 Nutrition Policy in the Member States UK White Paper on Public Health In the light of concern about rising rates of obesity in the UK, a White Paper on Public Health was produced in November 2004.42 The Paper noted that the promotion of health, communicating information on healthy eating and physical activity were key to meeting this new challenge. Central to achieving this aim would be providing people with the possibility of making informed choices about the food that they eat. Funding campaigns through non-governmental organisations and encouraging industry involvement in providing clear information about healthy eating would be used. In particular, messages relating to health and nutrition would have to be provided in shops and on packaging to ensure that they reach consumers at the time they make purchasing choices. The White Paper noted that consumers had begun to understand the importance of a diet with reduced salt, fat and sugar content. However, they were prevented from making meaningful choices to improve their diet, because the information on labels relating to salt, fat and sugar content was expressed in terms that were difficult to comprehend. As a result, the UK Government had to lobby for changes to current nutrition labelling requirements. It called for their simplification. It also suggested mandatory inclusion of the relevant information on all prepackaged foods. At domestic level, a new system of food labelling was to be devised, by mid-2005, that would ‘signpost’ fat, salt and sugar levels in order to build on existing nutrition labelling information. The idea was that consumers would be able to identify foodstuffs containing high levels of such substances. The ultimate aim was that by early 2006 a clear, straightforward code system would be in common use, providing obvious information on whether foods were making either a positive or a negative contribution to diet. The UK Food Standards Agency devised this signpost labelling system in March 2006. Colour-coded information would be provided on the front of food labels indicating levels of fat, saturated fat, sugar and salt. The system would work like traffic lights. Red would indicate a high level of these nutrients. Amber would indicate a medium level, and green a low level. Information would also be provided on the level of nutrients per portion of product. The standards set for the use of each colour followed those set out in the regulation on the use of nutrition and health claims and Codex Alimentarius guidelines. Therefore, in order to be able to use a green shaded area indicating low fat levels, the actual fat content would have to be below 3 g per 100 g or 1.5 g per 100 ml. Medium fat levels were set at between 3 g per 100 g or 1.5 g per 100 ml and 20 g per 100 g or 10 g per 100 ml. High fat 42 UK Public Health White Paper, Choosing Health: Making Health Choices Easier, Department of Health, London, 2004.

(G) MacMaolin Ch6

9/2/07

15:17

Page 235

6.3 Nutrition Policy and Free Movement 235 content, indicated by a red shaded area, was set at over 20 g per 100 g or 10 g per 100 ml. A foodstuff was deemed to be high in salt when actual salt content rises above 1.5 g per 100 g or 100 ml. There is a major difficulty facing any Member State that devises a scheme using signposting labelling: given the way in which EU rules on free movement have developed, such schemes cannot become compulsory. They must remain voluntary. Member States cannot impose these labelling requirements on producers from other Member States owing to the existence of Article 28 EC, the principle of mutual recognition and the limited scope accorded to Member States on the application of Article 30 EC exceptions. The obvious detriments of this situation are evident in the manner in which the scheme has been applied thus far in the UK. Most major retailers have lent their support to the scheme. However, this support only extends to their own-brand products. It is up to individual producers to follow their lead. In addition to this, each retailer has devised its own variation of the scheme. In July 2006, 14 different signpost label types were identified, none of which were identical to the UK Food Standards Agency model label. Nine of these were developed by the retailers themselves. The other five were devised by major food manufacturers. Some use bar charts to display the colour coded information. Others use pie charts, graphs, logos, lists and symbols. All this meant that, given that the UK is not legally in a position to oblige producers and retailers to adopt a standard form of labelling, as of July 2006, only four months after the introduction of the scheme, the consumer shopping in a UK supermarket could be faced with up to six different types of nutrition signpost labelling. The primary motivation behind the system was to present consumers with clear labelling information on nutrition levels so that they could make informed choices for the benefit of their diet and health. There is possibly one saving factor in devising a food labelling scheme such as this. The free movement rules that currently scupper the chance of creating a standard label could, in the future, be used to develop a Community-wide nutrition signpost label. If a significant number of Member States were to develop a similar scheme, the Commission might feel compelled to create a harmonised EU label, perhaps something similar to the eco-label.43 At present, only a handful have such a system in place, such as the UK and Sweden, while several others, for example the Netherlands and Denmark, are considering similar moves. Folic Acid Fortification Member States must, of course, take EU free movement rules into consideration when setting national rules on the composition of foodstuffs. As discussed in Chapter 2, the general rule is that any such domestic legislation contravenes Article 28 EC where it inhibits, or has the potential to inhibit, intra-Community 43 Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme. [2000] OJ L 237/1.

(G) MacMaolin Ch6

9/2/07

15:17

Page 236

236 Nutrition Law and Policy in the EU food trade. However, in some circumstances Member States may be permitted to introduce such requirements to protect human health. An example of this can be seen in relation to Ireland’s proposal to fortify bread with folic acid, with the intention of reducing the number of babies born with neural tube defects, such as spina bifida. Evidence from the USA and Canada suggested that such a policy was effective there. Initially, the Food Safety Authority of Ireland Scientific Committee and Nutrition Sub-Committee recommended the mandatory fortification of flour with folic acid in 2003. The following year, the Irish Government established a National Committee on Folic Acid Fortification, with the Food Safety Authority of Ireland acting as its secretariat, with the aim of reviewing the options that may be available for the fortification of foods in this way. Research in Ireland demonstrated that a policy of recommending that women of child-bearing age take folic acid supplements was generally ineffective. There were three reasons for this: the high proportion of unplanned pregnancies, inadequate knowledge amongst women about the benefits of taking folic acid, and the cost of purchasing the necessary supplements. Given that 97 per cent of women in Ireland eat bread on a daily basis, it was chosen as the best medium for fortification. Three potential ways of achieving the desired increase in folic acid intake were identified: voluntary addition by producers of breads that would then carry an appropriate health claim on the label, mandatory fortification to ensure that a targeted level of folic acid was present in all breads, and a continuation of the existing policy of health promotion campaigns. A consultative process commenced. The National Committee on Folic Acid Fortification reported in July 2006 that, following on from the response to calls for consultation, over three quarters of those who expressed an opinion favoured mandatory fortification. It is thus proposed that all bread manufactured or marketed in Ireland, with the exception of some minor bread products, should be fortified with folic acid on a mandatory basis. The Report noted that up to 10 per cent of bread sold in Ireland was imported, primarily from the UK. These products would now, under the proposals, be required to alter their folic acid levels in order to be lawfully marketable in Ireland—seemingly at odds with Community rules on free movement, in particular the decision in Cassis. However, rules such as these on mandatory fortification are allowable under EU law where they are justifiable on health protection grounds. The Member State must inform the Commission of any new standards such as this that it sets for food products, advising on the reasons as to why this action is necessary.44 Proposals for a regulation on the addition of vitamins and minerals to foods make specific provision for Member States to require the mandatory fortification of foods, in particular where dictated by public health considerations that are relevant to the national or regional level.45 Ireland should 44 Directive 1998/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations. [1998] OJ L 204/37. 45 Articles 9 and 14 of the Proposal for a Regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods. COM (2003) 671.

(G) MacMaolin Ch6

9/2/07

15:17

Page 237

6.3 Nutrition Policy and Free Movement 237 be able to satisfy a requirement such as this as the data clearly shows that there is a higher than average rate of babies born with neural tube defects in Ireland as compared with other Member States. The evidence presented in support of the mandatory fortification of bread also demonstrated that this approach could greatly assist in preventing the development of such defects by around 70 per cent. Determining Member State Autonomy in Health Protection Measures The preceding discussion on UK efforts to combat poor diet and Irish attempts to reduce the number of babies born with neural tube defects illustrates one of the primary deficiencies of EU food law and its interaction with free movement policy. As discussed in detail in Chapter 2, the case law on Article 28 EC makes it quite clear that Member States are not in a position to justify any national measures that restrict intra-Community trade on the ground that it is necessary to improve the nutritional content of food. Claims that it is necessary to protect human health, and therefore capable of justification under the terms of Article 30 EC, are generally dismissed, the Court indicating that these national measures are in fact a disguised restriction on free movement. This results in a situation whereby Member States may only take action where there is an identifiable risk to human health. One example would be the risk that may arise from a folic acid deficiency in pregnant women. However, Member States are precluded from attempting to improve diets in order to counter increasing rates of obesity, which could be achieved by introducing signpost labelling clearly identifying foods harmful to the consumer. In terms of overall human health, the actual impact of chronic consumption of foods causing obesity is much higher than the adverse effects of various food scares. Take Ireland as an example once more. The Report of the National Committee on Folic Acid Food Fortification estimated that each year, between 49 and 93 babies born in Ireland are affected by neural tube defects, one of the highest rates in the EU. Compare this to the facts set out in the launch of a National Taskforce on Obesity in March 2004. There it was stated that obesity accounts for at least 2,500 deaths in Ireland each year, affecting 14 per cent of men and 12 per cent of women, causing diabetes, heart disease, cancer and high blood pressure. Despite this, no legislative action on food labelling or on the compulsory improvement of the nutritional content of food is allowable because of EU rules on the free movement of goods. Such legislation would be contrary to Article 28 EC and its related case law: it would mean that foods lawfully marketed elsewhere in the Community would either be prohibited in Ireland, or would have to be marketed in Ireland with specific labelling, packaging or compositional content. This would be in clear contravention of the principle of mutual recognition. 6.3.2 EU Nutrition Policy Member States have begun to intervene at the national level to counter increasing obesity rates. As illustrated above, the measures that they can take to implement

(G) MacMaolin Ch6

9/2/07

15:17

Page 238

238 Nutrition Law and Policy in the EU these policies are limited by EU rules on free movement. However, the EU itself has now embarked upon a programme of measures that could be adopted to assist here. This commenced with the publication of a Green Paper on Promoting Healthy Diets and Physical Activity, in December 2005.46 The Paper notes that unhealthy diet, along with a lack of physical activity, are the two main causes of avoidable illness and premature death in the EU. Evidence presented suggests that EU obesity levels have risen by between 10 and 40 per cent over the past 10 years, affecting up to 27 per cent of men and 38 per cent of women.47 In some Member States, over half the adult population is overweight,48 rising to over 67 per cent in seven Member States.49 The number of children affected in the EU is estimated to be rising by over 400,000 a year. One in four children is overweight.50 The main causes of obesity are recognised as being high intake of energy-dense micronutrient foods and sugar sweetened soft drinks.51 Dutch studies estimate that excessive intake of trans fatty acids (unsaturated fatty acids produced by partial hydrogenation of vegetable oils) increases the risk of cardiovascular disease by 25 per cent.52 Obesity has an economic cost as well. It has been estimated that obesity accounts for at least seven per cent of all health case costs in the EU.53 This figure probably stands at over 10 per cent in 2006. The UK National Audit Office estimated that obesity in England alone accounted for 18,000,000 sick days from work, 30,000 premature deaths and a cost to the National Health Service in excess of £500 million, in 2001. The wider costs to the economy, including lower productivity and lost output, amount to £2 billion per year.54 In Ireland, the estimated cost of treating obesity-related illnesses was estimated at €70 million in 2002.55 The Green Paper suggests that several courses of action are open to the EU institutions to assist in tackling this epidemic. Practically all involve the provision of advice and encouragement on better diet and lifestyles. These include providing a role for EFSA which, it is stated, ‘can make an important contribution to underpinning proposed actions on nutrition . . . with scientific advice and assistance’.56 It is also stated that consumers should not be misled by advertising for foods with high fat, salt or sugar content. It is suggested that industry self-regulation could be the means of choice here. Improving public knowledge on the relationship 46 Commission Green Paper on Promoting Healthy Diets and Physical Activity: A European Dimension for the Prevention of Overweight, Obesity and Chronic Diseases. COM (2005) 637. 47 Annex 2 to the Green Paper. 48 WHO, European Health Report, 2002. 49 Finland, Germany, Greece, Cyprus, Czech Republic, Slovakia and Malta. 50 International Obesity Task Force, Childhood Obesity Report, May 2004. 51 Annex 2 to the Green Paper. 52 RIVM Report, Measuring Dutch Meals: Healthy Diet and Safe Food in the Netherlands. See also D Mozaffarian et al, ‘Trans Fatty Acids and Cardiovascular Disease’ (2006) 354 New England Journal of Medicine 1601. 53 WHO, Obesity—Preventing and Managing the Global Epidemic, 1998 (Technical Report Series No 894). 54 National Audit Office, Tackling Obesity in England, 2001. 55 Report of the National Taskforce on Obesity, Obesity—The Policy Challenges, 2005. 56 Green Paper, section IV.5.1.

(G) MacMaolin Ch6

9/2/07

15:17

Page 239

6.4 Conclusion 239 between diet and health, energy intake and output, on diets that lower the risk of chronic diseases, and on healthy choices of food items, is seen to be a prerequisite for the success of any nutrition policy, whether at national or Community level. Therefore ‘consistent, coherent, simple and clear messages need to be developed, and disseminated through multiple channels and in forms appropriate to local culture, age and gender’. Children should be ‘guided towards healthy behaviours’. The only references to legislative intervention in the Green Paper are in relation to considering amendments to existing rules on nutrition labelling and on the proposal for a regulation on health and nutrition claims. Key to the proper functioning of this regulation is ‘the principle of setting nutrient profiles, in order to prevent foods high in certain nutrients (such as salt, fat, saturated fat and sugars) making claims about their potential nutrition or health benefits’. Finally, it is stated that: A coherent and comprehensive approach aimed at making the healthy choices available, affordable and attractive involves taking account of mainstreaming nutrition and physical activity into all relevant policies at local, regional, national and European levels, creating the necessary supporting environments, and developing and applying the appropriate tools for assessing the impact of other policies on nutritional health and physical health.57

It is here contended that this ‘supporting environment’ cannot properly exist given the nature of, and priority accorded to, free movement principles. It is only where the EU has not taken action that the Member States may be able to introduce their own measures to help prevent bad health arising from poor diet.58 The fact that the Community has not acted, has enabled Denmark to introduce its own rules limiting the amount of trans fatty acids in food. However, the jurisprudence of the Court of Justice indicates that were such national rules to be challenged by an importer into Denmark of food containing a level of trans fatty acids exceeding the permitted level, Danish law would be declared contrary to Article 28 EC. As discussed in Chapter 2, national rules designed to improve the nutritional content of food are not normally deemed justifiable under the terms of Article 30 EC, on health protection grounds.59 6.4 CONCLUSION

The most serious health concern relating to food in the European Union is obesity. The first step in tackling this problem is to get consumers to alter their diet. 57

Ibid, section V.8.1. See, in particular, Case 174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445, para 16; Case 178/1984, Commission v Germany (bier) [1987] ECR 1227, paras 28 and 41; Case C-24/2000, Commission v France (fortified foods-‘Red Bull’) [2004] ECR I-1277, para 49. 59 See, in particular, Case 216/1984, Commission v France (milk substitutes) [1988] ECR 793, para 15; Case 274/1987, Commission v Germany (meat products) [1989] ECR 229, para 10; Case-17/1993, Criminal proceedings against Van der Veldt [1994] ECR I-3537, paras 17–21; Case C-123/2000, Criminal proceedings against Christina Bellamy and English Shop Wholesale SA [2001] ECR I-2745, para 12. 58

(G) MacMaolin Ch6

9/2/07

15:17

Page 240

240 Nutrition Law and Policy in the EU However, many appear unwilling to do so. Where Member States want to intervene, in order to assist in behavioural change, they are prevented from doing so by EU law. There is no shortage at national level of initiatives designed to combat dietary excesses and deficiencies. Most revolve around providing information and education, rather than compelling the food industry to ensure that its products are of sufficient nutritional value, or if not, to clarify the position for the consumer. It is only the latter approach that can have any real and lasting impact. The UK system of signpost labelling, for example, has become unworkable and impractical because it cannot be standardised. Efforts to create clarity for consumers consequently create more confusion.60 There are two main reasons why Member States cannot be more interventionist when it comes to dealing with a health crisis like obesity. The first is that the manner in which the Article 28 EC jurisprudence on measures equivalent to quantitative restrictions on imports prevents national authorities maintaining laws to compel improvements to the nutritional content of food. This is not deemed to be a legitimate human health-based exception to the general rule on free movement. Second, the fact that nutrition labelling rules already exist at Community level prevents the Member States from obliging producers to adopt any alternative system for providing this type of information. This is still so, despite the fact that the Community nutrition label is only obligatory for foodstuffs where a health or nutrition claim is made. All other products need not carry this data at all. The present method for displaying this information is also deemed to be unclear to the average consumer. The Community institutions have proved unwilling to adopt measures that could assist the Member States in any efforts that they wish to make in this regard. The Commission Green Paper makes reference to the regulation on nutrition and health claims, and in particular how the nutrient profiles will prevent unhealthy foods from making dishonest health claims. Subsequently, through the alterations to the proposal for this legislation via the Article 251 EC procedure, its content has now been altered by the Council and the Parliament. This system of profiling is virtually meaningless given that a product may now be high, even very high, in one of the deadly constituents of food (fat, saturated fat, sugar or salt) and still claim to be of high nutritional value or good for human health. Until Member States are provided with more flexibility to act, or until sufficient and meaningful harmonised standards are introduced at Community level, the obesity crisis, by far the most serious food-related crisis to affect the EU since its inception, affecting infinitely more consumers than BSE ever has, is unlikely to be averted. 60 Recent calls for additional labelling disclosures about trans fatty acid content in food may not therefore present the best method of alerting consumers to their presence in foodstuffs. See R Clarke and S Lewington, ‘Trans Fatty Acids and Coronary Heart Disease’ (2006) 333 British Medical Journal 214. It is not necessarily the information that is disclosed that is important. It may, however, be the manner in which it is disclosed that really affects consumer decision-making. For more on this see JC Kozup et al, ‘The Provision of Trans Fat Information and its Interaction with Consumer Knowledge’ (2006) 40 Journal of Consumer Affairs 163 where it is argued that without accompanying consumer education, new labelling regulations on the presence of trans fats may be limited.

(H) MacMaolin Ch7

9/2/07

15:17

Page 241

7 Contemporary Considerations for EU Food Law 7.1 INTRODUCTION

T

HE ARGUMENT PRESENTED thus far has contended that the manner in which Community law on the free movement of goods has developed, frustrates the proper protection by Member States of human health and consumers. This situation persists despite the fact that the EC Treaty clearly leaves a large degree of competence to the Member States in these matters. Article 30 EC is designed to enable the Member States to breach free movement rules in order, among other things, to protect human health. Article 152 EC states that Community action on health protection is designed to complement national policies.1 Article 153 EC enables the Community to contribute to ensuring that consumers are protected by measures which support and supplement the policies of the Member States. The development of the mandatory requirements by the Court in Cassis should also assist in this regard. In addition to the consideration outlined above, EU food law must also respond to changes to the manner in which food is produced and alterations to consumer preferences. Attempts to deal with advancements in these areas at Community level have not always proved successful. Given that consumers in the different Member States are not all likely to want the same things at the same time, and given that there will always be tension between the economic needs of producers and the reluctance of consumers to accept new innovations in the technology and science of producing food, Community law which seeks to standardise rules on these matters across 25 Member States simultaneously will generally prove to be a difficult task. 7.2 INNOVATION IN FOOD PRODUCTION: GENETIC MODIFICATION

Genetically modified organisms (gmos) are, to give them their legal definition, any life form, with the exception of human beings, in which the genetic material has 1 For further discussion on the division of competences under Article 152 EC see T Hervey, ‘Community and National Competence in Health after Tobacco Advertising’ (2001) 38 Common Market Law Review 1421.

(H) MacMaolin Ch7

9/2/07

15:17

Page 242

242 Contemporary Considerations for EU Food Law been altered in a way that does not occur by natural reproduction.2 There are two distinct, yet related, arguments surrounding the introduction of genetic modification technology. The first relates to environmental concerns. In general terms, environmentalists are anxious about the type of damage that may be caused by alterations to agricultural methods used in genetic modification techniques, such as the potential impact on farmland wildlife of herbicide use associated with genetically modified crops. United Kingdom government-backed farm-scale trials on growing such crops led to mixed evidence on the potential harm of genetic modification techniques. Initial results suggested that growing genetically modified beet and rape was less environmentally friendly than growing their conventional counterparts. In contrast, growing genetically modified herbicide-tolerant maize was better for many groups of wildlife than conventional maize.3 There were more weeds in and around these maize crops, more butterflies and bees around at certain times of the year, and more weed seeds providing a food source for birds. The most recent studies now suggest that the cultivation of genetically modified herbicide-tolerant sugar beet crops can also clearly benefit the environment in similar ways.4 The second key interest regarding the cultivation of genetically modified crops, the one with which this book is primarily concerned, is that their presence in human foodstuffs and animal feed may have detrimental effects on human health. The science supporting such fears remains mixed, although there is an increasing body of evidence suggesting that there is little or no potential harm in consuming 2 Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and replacing Council Directive 1990/220/EEC. [2001] OJ L 106/1. For further discussion, see also Chapter 9 of M Lee, EU Environmental Law: Challenges, Change and Decision-Making (Oxford, Hart Publishing, 2005). 3 For a scientific evaluation of these findings see DR Brooks et al, ‘Invertebrate Responses to the Management of Genetically Modified Herbicide-tolerant and Conventional Spring Crops’ (2003) 358 Philosophical Transactions of the Royal Society 1847; GT Champion et al, ‘Crop Management and Agronomic Context of the Farm Scale Evaluations of Genetically Modified Herbicide-tolerant Crops’ (2003) 358 Philosophical Transactions of the Royal Society 1801; AJ Haughton et al, ‘Invertebrate Responses to the Management of Genetically Modified Herbicide-tolerant and Conventional Spring Crops’ (2003) 358 Philosophical Transactions of the Royal Society 1863; C Hawes et al, ‘Responses of Plants and Invertebrate Trophic Groups to Contrasting Herbicide Regimes in the Farm Scale Evaluations of Genetically Modified Herbicide-tolerant Crops’ (2003) 358 Philosophical Transactions of the Royal Society 1899; MS Heard et al, ‘Weeds in Fields with Contrasting Conventional and Genetically Modified Herbicide-tolerant Crops’ (2003) 358 Philosophical Transactions of the Royal Society 1819; DB Roy et al, ‘Invertebrates and Vegetation of Field Margins Adjacent to Crops Subject to Contrasting Herbicide Regimes in the Farm Scale Evaluations of Genetically Modified Herbicidetolerant Crops’ (2003) 358 Philosophical Transactions of the Royal Society 1879. A summary of the scientific evaluations is available in LG Firbank et al, ‘The Implications of Spring-sown Genetically Modified Herbicide-tolerant Crops for Farmland Biodiversity: A Commentary on the Farm Scale Evaluations of Spring Sown Crops’, www.defra.gov.uk/environmant/gm/fse/results/fsecommentary.pdf. The data from these evaluations is available at www.farmscale.org.uk. 4 MJ May et al, ‘Management of Genetically Modified Herbicide-tolerant Sugar Beet for Spring and Autumn Environmental Benefit’ (2005) 272 Proceedings of the Royal Society: Biological Sciences 111. This research demonstrates that the use of the herbicides could increase weed seed production by up to 16 times its normal level as compared to conventional systems, thus providing birds with an abundant autumn food source.

(H) MacMaolin Ch7

9/2/07

15:17

Page 243

7.2 Genetic Modification 243 genetically modified food.5 Despite this, consumer groups, by and large, remain firmly opposed to the presence of genetically altered ingredients in their foodstuffs. This is especially so since 1999, when it was suggested that genetically modified potatoes might be toxic to laboratory rats.6 The subsequent public outcry led to the introduction of an unofficial moratorium on the growth and importation of genetically modified crops in the European Union, which was not lifted until new regulations were introduced in late 2003.7 This action has also been the subject of dispute at WTO level.

7.2.1 GMO Regulatory Framework European Union regulators have sought to appease consumer concerns about the use of genetic modification techniques in food production by introducing legal controls over the placing of these products on the market, and by ensuring that consumers are made fully aware of their presence in food products. The former is managed through notification and authorisation procedures, the latter by the introduction of clear labelling requirements. The legal framework designed to control the use of genetic modification in food production is now based primarily on four instruments, three regulations and a directive. The first gmo directives were introduced in 1990, setting a framework of rules for their contained use in laboratories and their deliberate release onto the 5 See, for example, S Roller, ‘Genetically Modified Foods: Threat or Opportunity?’ (2001) 39 Food Technology and Biotechnology 259; R Edwards, ‘We Are No Nearer to Knowing if Genetically Modified Food is Safe’ (2000) 165 (2228) New Scientist 5; L Donaldson and R May, Health Implications of Genetically Modified Foods (London, Department of Health, 1999); Institute of Food Science and Technology, Genetic Modification and Food (London, IFST, 1999). 6 SWB Ewen and A Pusztai, ‘Effect of Diets Containing Genetically Modified Potatoes Expressing Galanthus Nivalis Lectin on Small Rat Intestine’ (1999) 354 The Lancet 1353. Eurobarometer surveys demonstrate that there is a high level of concern amongst consumers over the safety of genetically modified food. Almost two thirds of respondents are concerned about the risks associated with genetically modified food (Eurobarometer 1997), nearly three quarters favour clear labelling of genetically modified food (Eurobarometer 1997), and more than half claim that they are willing to pay more for nongenetically modified food (Eurobarometer 2000). Other surveys show similar concerns, for example, a March 1997 survey conducted by the University of Lancaster for Unilever finds ‘significant unease about the technology as a whole . . . and much such unease is latent rather than explicit’; an August 1997 survey conducted by Market Measures Ltd for J Sainsbury plc reveals that UK consumers do not favour genetically modified foods because they are ‘unnatural’; over half of those aware of genetically engineered food said they would ‘probably not’ or ‘definitely not’ buy such food (AgBiotechNet 1997); a March 1998 Gallup poll commissioned by Iceland Foods plc showed that 63 per cent of respondents who were aware of genetically modified food had reservations; a MORI poll indicated a lower degree of distrust of genetically engineered food in Britain where 53 per cent of respondents claimed that they would not eat genetically engineered food, against 63 per cent of Danes, 65 per cent of Italians and Dutch, 77 per cent of French and 78 per cent of Swedes (www.centerfoodsafety.org/facts&issues/ polls.htm). 7 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. [2003] OJ L 268/1: Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. [2003] OJ L 268/24.

(H) MacMaolin Ch7

9/2/07

15:17

Page 244

244 Contemporary Considerations for EU Food Law marketplace.8 This was followed by a novel foods regulation in 1997,9 and, after a series of amendments primarily designed to close loopholes that had allowed certain genetically modified foods to escape the key regulatory provisions, a new deliberate directive was introduced in 2001.10 Deeming this to be an insufficient response to the circumstances that had led to the need to introduce a moratorium, two regulations were devised and brought into force in 2003.11 Of these, the original contained use directive, the novel foods regulation, the new deliberate release directive and the two new regulations on genetically modified food and feed and on traceability and labelling now form the European Union legal framework for the regulation of genetic modification processes in food production and marketing. Novel Foods Regulation Novel foods are those which have not previously been used for human consumption to any significant degree within the Community, generally due to an alteration in their genetic material or molecular structure, including foods and ingredients containing or consisting of, or produced from but not containing, gmos.12 The regulation does not apply to additives or flavourings already subject to Community legislation,13 provided that there are corresponding safety standards laid down therein.14 The primary purpose of the regulation is to ensure that any novel food does not harm or mislead consumers in any way, including ensuring that such foods do not differ from the foods that they are intended to replace to such an extent that the normal consumption of the novel food would be nutritionally disadvantageous for the consumer.15 This is to be ensured primarily by an application and notification procedure for the placing of novel foods on the market, which should disclose details of the studies and assessment of compliance

8 Council Directive 1990/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms. [1990] OJ L 117/1; Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms. [1990] OJ L 117/15. 9 European Parliament and Council Regulation (EC) No 258/1997 of 27 January 1997 concerning novel foods and novel food ingredients. [1997] OJ L 43/1. 10 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and replacing Council Directive 1990/220/EEC. [2001] OJ L 106/1. 11 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. [2003] OJ L 268/1; Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. [2003] OJ L 268/24. 12 Article 1(2). 13 Such as Council Directive 1989/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. [1989] OJ L 40/27; Council Directive 1988/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production. [1988] OJ L 184/61. 14 Article 2(2) of the Novel Foods Regulation. 15 Article 3(1).

(H) MacMaolin Ch7

9/2/07

15:17

Page 245

7.2 Genetic Modification 245 with the safety standards carried out, as set down in the regulation.16 An additional assessment of adherence may be required in some circumstances.17 After an initial assessment report is drafted and made available, Member States and the Commission may object to the marketing of the food or ingredient concerned. Objections may also be made regarding the proposed labelling or presentation of the novel food.18 Where this happens, the Commission is to seek the opinion of the Committee on the Food Chain and Animal Health (formerly the Standing Committee for Foodstuffs) on the measures that it proposes to take to counter any objections. Where the Commission and Committee cannot agree on the proposed measures, the matter is to be referred to the Council to decide what measures to take.19 The regulation sets out specific labelling requirements for novel foods, beyond those normally required by Community legislation.20 These are designed to inform the consumer about any characteristic or food property such as composition or nutritional value which makes a novel food different to similar existing foods.21 A novel food is deemed to differ from its conventional counterpart where scientific assessment demonstrates that the characteristics of the foodstuff vary to a certain degree from the natural variety. Where this is the case, the labelling is to specify which characteristics have been modified and the method by which those characteristics were modified, indicating clearly the presence in the novel food of this altering material including, where necessary, the presence of a gmo.22 Finally, where a Member State has grounds to consider that a novel food may endanger human health, even where it has been introduced in compliance with all relevant procedures, that State may suspend trade in, or prevent use of, the food. This power of suspension or prevention is referred to as the ‘safeguard clause’. The Commission must be immediately informed of any such action, and the reasons underlying such a decision should be disclosed. The Commission will then consider these grounds and, along with the Committee on the Food Chain and Animal Health, make a decision on the appropriate measures to be taken in the circumstances.23

16 Articles 4, 5, 6 and 7. Fifty-three applications for approval under the terms of Regulation 258/1997 were made between May 1997 and May 2004. Two of these applications were refused. Source: http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm. 17 Article 6(3). 18 Article 6(4). 19 Article 13. 20 In particular, Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 21 Article 8. 22 Article 8(1). 23 Article 12.

(H) MacMaolin Ch7

9/2/07

15:17

Page 246

246 Contemporary Considerations for EU Food Law Deliberate Release Directive The original deliberate release directive of 1990 presented a very general framework for the regulation of genetically modified food in the European Union.24 It set out the definition for gmos,25 specified the circumstances in which they could be used,26 and established a notification system for their use for research purposes27 and for their being placed on the market.28 The primary failing of the directive, as discussed below, was that it failed to set any specific labelling requirements for genetically modified food. It merely stated that where such a product was placed on the market, notification of this was to include information on the proposed labelling, which should contain, at least in summarised form, details of the name of the product and any gmos contained therein, the name of the manufacturer, any conditions of use, and instructions for storage or handling.29 This was insufficient to satisfy the impending levels of unrest about the use of genetic modification in food production that was to come a few years later. The new deliberate release directive was introduced in 2001 to address the shortcomings of its predecessor.30 It is clear from the outset that Directive 2001/18 is largely moulded by a vastly increased consideration for consumer concerns, an input that was largely missing from the provisions of Directive 1990/220. Any measures taken in relation to genetically modified food are now to be based firmly around full use of the precautionary principle, from both an environmental and a human health protection perspective.31 There is to be closer scrutiny of potential adverse health effects, with Member States and the Commission being compelled to assess any such possible dangers on a case by case basis.32 There is to be greater enforcement and monitoring of compliance with the provisions of the directive at national level, and the course of action to be taken in the event of non-compliance is made much more explicit.33 Where a foodstuff makes its way onto the marketplace without first adhering to all the terms of the legislation it is to be immediately withdrawn and consumers, the Commission and the other Member States are to be immediately informed about this.34 The directive also paved the way

24 Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms. [1990] OJ L 117/15. 25 Article 2(2). 26 Article 15 in conjunction with compliance with Articles 5 to 14 of the Directive. 27 Articles 5 and 6 and Annex II. 28 Articles 11 and 12 and Annex II. 29 Annex III to Directive 1990/220/EEC. 30 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and replacing Council Directive 1990/220/EEC. [2001] OJ L 106. 31 Article 4(1). For further discussion on the use of the precautionary approach in genetic modification regulation see ZK Forsman, ‘Community Regulation of Genetically Modified Organisms: A Difficult Relationship between Law and Science’ (2004) 10 European Law Journal 580. 32 Article 4(3). 33 Article 4(5). 34 Ibid.

(H) MacMaolin Ch7

9/2/07

15:17

Page 247

7.2 Genetic Modification 247 for the implementation of the Cartagena Protocol on Biosafety into Community law.35 The compulsory notification procedure is set out in much more detail in Directive 2001/18 than that specified when the procedure was first promulgated in 1990. Information must be submitted regarding the results of any research into the use of the gmo, the environmental risk assessment, conditions of use, continued safety monitoring plans, the proposed packaging of the product, and proposed time limitations for the validity of the consent to run, for up to a maximum of 10 years.36 Most importantly, the directive makes it quite clear that any proposal for the labelling of genetically modified foods must demonstrate that it will be stated clearly on the label, or on an accompanying document, that ‘this product contains genetically modified organisms’.37 Member States are to ensure that the labelling and packaging of genetically modified foods comply fully with these requirements.38 The directive specifies that while, in conformity with the general principles of Community law, it is left to the discretion of the Member States to determine what penalties to impose where the national implementing provisions are deemed to have been breached, they are to offer an ‘effective, proportionate and dissuasive’ remedy.39 Member States may also temporarily prohibit the sale of a genetically modified food where they have detailed grounds for considering that it may pose a danger to human health.40 Any such move would have to be supported by a risk assessment meeting the required standards of independence, excellence and transparency. Genetically Modified Food and Feed Regulation The general genetically modified food and feed regulation41 is, according to Article 1, tied to the new general principles of EU food law established by Regulation 178/2002.42 Primarily, it is to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed, whilst also ensuring the effective functioning of the internal market. In order to achieve this, the general genetically modified food and feed regulation sets out a detailed authorisation procedure for the use of these products to be applied in each of the Member States. It also contains provisions on labelling requirements, thus 35

Article 32. Article 13(2). 37 Article 13(2)(f). 38 Article 21(1). 39 Article 33. 40 Article 23(1). 41 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. [2003] OJ L 268/1. 42 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. [2002] OJ L 31/1. 36

(H) MacMaolin Ch7

9/2/07

15:17

Page 248

248 Contemporary Considerations for EU Food Law meaning that the same or similar labelling requirements for genetically modified food are stipulated in three linked pieces of Community secondary legislation. This unnecessary duplication has added to the avoidable complications that already surround European Union genetically modified food labelling requirements. This is discussed in more detail below. Two distinct forms of authorisation procedure are set by the general genetically modified food and feed regulation, one for food intended for human consumption and one for animal feed. Where a product is likely to be used as both food and feed, then one single application will be considered.43 Food containing or consisting of, or food produced from, a gmo may only apply for authorisation if it does not have adverse effects on human health, animal health or the environment; if it does not mislead the consumer in any way; and if it does not differ in any way from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous.44 Obviously enough, under the terms of the regulation, no genetically modified food can be marketed in the EU unless it has received authorisation, following a clear demonstration that the product is safe.45 This authorisation procedure applies to all products coming within the scope of the regulation. The labelling requirements set out therein, as well as those prescribed by the deliberate release directive and the labelling and traceability regulation, however, only apply to foodstuffs that actually contain or consist of a gmo. Food produced from but not containing a gmo in the finished product is exempt from all the additional labelling requirements set for such products. The authorisation procedure is as follows. The application is sent to the national competent authority of a Member State, for example the Department for Environment Food and Rural Affairs (DEFRA) in the United Kingdom or the Environmental Protection Agency (EPA) in Ireland. The national authority must acknowledge receipt of the application in writing within 14 days of its receipt. This information is then passed on to the European Food Safety Authority, which in turn informs the other Member States and the Commission about the application and its content. A summary of this dossier is also to be made available to the public. The application itself should include information about the applicant; the name of the food; a detailed description of the method of production; copies of the relevant studies that have been carried out, in particular independent peerreviewed studies; data and analysis demonstrating that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations of such characteristics; a proposal for the labelling of the food; a reasoned statement that the food does not give rise to ethical or religious concerns; conditions for use and handling; methods for the detection, sampling and identification of the modification processes that the food 43 44 45

Article 27. Article 4(1). Article 4(2) and (3).

(H) MacMaolin Ch7

9/2/07

15:17

Page 249

7.2 Genetic Modification 249 has undergone; samples of the food; proposals for post-market monitoring regarding use of the food for human consumption; and a summary of the dossier in a standardised form. This authorisation procedure applies to all genetically modified food, both that containing or consisting of a gmo and that produced from but not ultimately containing a gmo. Applications for authorisation to use foods containing or consisting of a gmo should also be accompanied by the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18, such as information on any previous use of the gmo, proposed packaging and proposed measures to be taken in the event of misuse, and information and conclusions about the environmental risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18, as well as a plan for monitoring the effects of the cultivation of the genetically modified food in question on the environment, as prescribed by Annex VII to the deliberate release directive.46 The European Food Safety Authority is required to give an opinion on the merits of the application for authorisation, generally within six months of its receipt. Supplementary information may be requested. After a detailed examination of the application, which may involve the Authority calling upon food assessment bodies within the Member States to evaluate the safety of the genetically modified food in question, the opinion is forwarded to the Commission, the Member States and the applicant. This opinion is also to be made available to the public, who in turn have 30 days to submit comments on its content to the Commission.47 Within three months of receiving the opinion of the European Food Safety Authority, the Commission is to submit a draft of the decision to be taken in respect of the application to the Standing Committee on the Food Chain and Animal Health.48 This decision is to be based upon the opinion of the Authority, other relevant provisions of Community law (in particular the free movement of goods and human health, consumer and environmental protection), and any other relevant factors. The Commission must provide a detailed explanation where this decision differs from the opinion of the European Food Safety Authority. The applicant is then to be informed of the outcome, which is also to be published in the Official Journal of the European Union. Authorisations granted are entered into a register, are valid for 10 years, are renewable, and are fully valid throughout the EU.49 Products already placed on the market under the terms of the original deliberate release directive or the novel foods regulation can continue to be marketed as such.50 46

Article 5. Article 6. 48 As established by Article 58 of Regulation (EC) No 178/2002. 49 Article 7. For further discussion on this procedure see E Brosset, ‘The Prior Authorisation Procedure Adopted for the Deliberate Release into the Environment of Genetically Modified Organisms: The Complexities of Balancing Community and National Competences’ (2004) 10 European Law Journal 555. 50 Article 8. 47

(H) MacMaolin Ch7

9/2/07

15:17

Page 250

250 Contemporary Considerations for EU Food Law A similar authorisation procedure is established for genetically modified animal feed.51 Labelling requirements are also set out here. Genetically modified animal feed must carry a statement on the labelling indicating this, either as a statement following the name of the feed or in a footnote to the list of feed, printed in a font the same size as text appearing elsewhere on the label. Any characteristics that render the genetically modified feed different from its conventional counterpart must also be disclosed. Where no conventional counterpart exists, information about the nature and characteristics of the feed must appear on the label.52 Labelling and Traceability Regulation The 2003 Labelling and Traceability Regulation both amends aspects of the deliberate release directive labelling regime and introduces a new framework for ensuring that genetically modified foods and ingredients can be traced at all stages of the food production process.53 The idea behind the introduction of new traceability requirements is to facilitate the withdrawal of products where unforeseen adverse effects on human health, animal health or the environment are established and to ensure the implementation of other precautionary-based risk management measures where necessary.54 Traceability requirements for food produced from gmos should also assist in ensuring the accuracy of the labelling on such products. The regulation also applies to genetically modified animal feed.55 The traceability requirements set out in the regulation for genetically modified food and feed are relatively uncomplicated. It is to be made clear in writing by the operator passing the product on at the initial stage of production, that the product consists of or contains a gmo. This statement is to be accompanied by a ‘unique identifier’ that has been assigned to the product.56 The unique identifier is a numeric or alphanumeric code which identifies the gmo and enables specific information pertinent to gmos of that type to be retrieved.57 This information is then to be passed on to operators at all subsequent stages of the production and marketing process.58 All operators involved in this food production and marketing chain are to ensure that they retain this information, along with details of those to whom the products were passed, for five years following each transaction.59

51

Articles 17–20. Article 25. Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and amending Directive 2001/18/EC. [2003] OJ L 268/24. 54 Preamble to Regulation 1830/2003. 55 Article 2(1). 56 Article 4(1). 57 Article 3. The Commission, under the terms of Article 8 of the Regulation, is to develop a system for the assignment of unique identifiers to genetically modified organisms, taking account of any relevant developments in international fora, such as the Codex Alimentarius Commission. 58 Article 4(2). 59 Article 4(4). 52 53

(H) MacMaolin Ch7

9/2/07

15:17

Page 251

7.2 Genetic Modification 251 The labelling requirements set out in the regulation clear up some of the unnecessary ambiguity surrounding the stipulations of Articles 13 and 21 of Directive 2001/18. Although the deliberate release directive makes it clear that products consisting of or containing gmos must state that ‘this product contains genetically modified organisms’ it does so in a circuitous way, prescribing that the required notification should indicate that such labelling should appear, but nowhere does it state explicitly that it must appear on the labelling of such products. Article 6 of the labelling and traceability regulation prescribes that for products consisting of or containing gmos, operators are to ensure that these words appear on the label of prepackaged products. For non-prepackaged products offered for sale to the final consumer this information must appear either on, or in connection with, the display of the product. These provisions on labelling and traceability do not apply to products that contain only a trace of a gmo, below the threshold levels prescribed by the deliberate release directive and the general genetically modified food regulation.60 Neither do they apply to foods produced from, but not containing, a gmo. Challenging the GMO Regulatory Framework: Labelling Difficulties Overall, EU food labelling requirements for genetically modified food are unnecessarily piecemeal and complex. Despite repeated efforts to remedy the situation, it has been this way since the introduction of the original deliberate release directive in 1990.61 The original deliberate release directive prescribed that prior to the placing of a gmo on the market, either as or in a product, notification of this had to be submitted to the competent authority in the respective Member State.62 This had to include details of the proposed labelling of the product, which should give, as a minimum, information relating to the name of the product and any gmos contained therein, the manufacturer, conditions of use, measures to be taken in the event of misuse and specific recommendations for storage or handling.63 The deliberate release directive was later amended, setting labelling requirements for foodstuffs produced using a mixture of genetically modified and non-genetically modified substances.64 It was now compulsory for the labels on such products to state that there was a possibility that they may contain gmos.65 60 Article 4. These threshold levels are set out in Articles 21(2) and 21(3) of Directive 2001/18 and Articles 12, 24 and 47 of Regulation 1829/2003. Regulation 1829/2003 sets this level at 0.5%. 61 Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms. [1990] OJ L 117/15. A directive was also introduced at the same time on the conducting of laboratory research into the use of genetically modified micro-organisms. Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms. [1990] OJ L 117/1. While Directive 1990/220 has since been replaced, Directive 1990/219 is still in force. 62 Article 11(1). 63 Annex III (B)(5) to Directive 1990/220/EEC. 64 Commission Directive 1997/35/EC of 18 June 1997 adapting to technical progress for the second time Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms. [1997] OJ L 169/72. 65 Annex to Directive 1997/35/EC.

(H) MacMaolin Ch7

9/2/07

15:17

Page 252

252 Contemporary Considerations for EU Food Law Additional labelling requirements were introduced for novel foods and novel food ingredients in 1997.66 It soon became apparent, however, that major shortcomings were emerging in the evolving body of genetically modified food labelling legislation. In particular, a new regulation had to be introduced to ensure that the same labelling rules would apply to foods and ingredients placed on the market both prior to and after the entry into force of the novel foods regulation.67 This was deemed necessary not only to prevent the acquisition of competitive advantages, but also because the original deliberate release directive did not set out any safety grounds upon which products containing either genetically modified soya or genetically modified maize would be brought within the scope of the novel foods regulation and would thus be subject to the additional labelling requirements prescribed by that regulation.68 Some Member States had introduced their own measures to deal with this failing. Such local action, it was noted, would be liable to impede the free movement of food and thereby adversely affect the proper functioning of the common market.69 The regulation introduced to remedy the discrepancy that had enabled products containing genetically modified soya or genetically modified maize to escape the labelling requirements set by the novel foods regulation fell some way short of achieving that aim.70 The general labelling rules laid down by the regulation did not clarify which soya and maize products would have to be labelled, or how they were to be labelled. Another new regulation, laying down more detailed rules, was thus introduced in 1998 in an attempt to conclusively allay any outstanding concerns regarding the labelling of these foodstuffs.71 However, under the terms of this new regulation the only products that were required to display a clear statement on the label that they contained genetically modified soya or genetically modified maize were those that were not required to include a list of ingredients

66 European Parliament and Council Regulation (EC) No 258/1997 of 27 January 1997 concerning novel foods and novel food ingredients. [1997] OJ L 43/1. 67 Commission Regulation (EC) No 1813/1997 of 19 September 1997 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 1979/112/EEC. [1997] OJ L 257/7. 68 Consent had originally been granted for the placing of these two foodstuffs on the market by Commission Decision 1996/281/EC of 3 April 1996 concerning the placing on the market of genetically modified soya beans (Glycine max L) with increased tolerance to the herbicide glyphosate, pursuant to Council Directive 1990/220/EEC. [1996] OJ L 107/10; Commission Decision 1997/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 1990/220/EEC. [1997] OJ L 31/69. 69 Preamble to Commission Regulation (EC) No 1813/1997. 70 Commission Regulation (EC) No 1813/1997. 71 Council Regulation (EC) No 1139/1998 of 26 May 1998 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 1979/112/EEC. [1998] OJ L 159/4. The stated aim of Regulation (EC) No 1139/1998 was to require that foodstuffs containing genetically modified soya beans or genetically modified maize would have to be clearly labelled as such. The statement ‘produced from genetically modified soya’ or ‘produced from genetically modified maize’, as appropriate, was to appear immediately after the name of the ingredient concerned. Article 2(3)(a).

(H) MacMaolin Ch7

9/2/07

15:17

Page 253

7.2 Genetic Modification 253 on the label at all.72 Under the terms of the framework food labelling directive73 the following foodstuffs do not have to display a list of ingredients on the label: untreated fresh fruit and vegetables, carbonated water, fermentation vinegars, cheese, butter, fermented milk and cream, and products consisting of a single ingredient.74 These are products that are highly unlikely to contain either genetically modified soya or genetically modified maize. Products actually containing the genetically modified ingredients only had to state that they contained these ingredients in the listing itself or as a footnote to it, and not in a prominent position on the front of the label as was previously considered necessary. The shortcomings of the 1998 soya and maize regulation were readily evident. By October of that year, Austria, dissatisfied with the Community provisions, had notified the Commission that it intended to issue a decree requiring that where a foodstuff contained any additives or flavourings produced by genetic engineering, this would have to be clearly indicated on the label. In response, the Commission took action on two fronts. First, it issued a decision requiring Austria to suspend the adoption of its draft decree on the matter.75 Second, it consulted with the other Member States regarding the Austrian proposal through the Standing Committee on Foodstuffs. It was recognised, as a result of this consultation, that consumers should be informed about the use of additives or flavourings that have been genetically modified in any way. The 1998 soya and maize regulation was later amended to allow foodstuffs containing up to one per cent of ingredients derived from gmos to be marketed without any indication of this on the label, provided that this presence is adventitious.76 A regulation was also introduced, setting additional labelling requirements for foodstuffs containing genetically modified additives or flavourings.77 Any foodstuff containing these ingredients must be labelled as such, either in the list of ingredients itself, or as a prominently displayed footnote to this list.78 72

Article 2(3)(b) of Regulation 1139/1998. Council Directive 1979/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer. [1979] OJ L 33/1. This Directive has since been replaced by Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. [2000] OJ L 109/29. 74 Article 6(2). 75 Commission Decision 1998/613/EC of 21 October 1998 concerning a draft Decree of the Republic of Austria on the identification of genetically modified additives and flavourings used as food ingredients. [1998] OJ L 291/35. 76 Commission Regulation (EC) No 49/2000 of 10 January 2000 amending Council Regulation (EC) No 1139/1998 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Council Directive 1979/112/EEC. [2000] OJ L 6/13. It has been suggested that detecting the presence of genetically modified ingredients constituting up to one per cent of the foodstuff can actually, given current testing methods, be very difficult. See P Cohen, ‘Telltale Traces: How Reliable are Official Tests for Genetically Modified Food?’ (2001) 170 (2286) New Scientist 16. 77 Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms. [2000] OJ L 6/15. 78 Article 4(1). 73

(H) MacMaolin Ch7

9/2/07

15:17

Page 254

254 Contemporary Considerations for EU Food Law The new deliberate release directive of 2001 prescribes that the statement ‘this product contains genetically modified organisms’ must appear either on a label or in a document accompanying genetically modified food.79 This is the key feature of the new deliberate release directive, as far as labelling requirements are concerned. It places a clear obligation on producers to state that a product contains a gmo where this is the case, a requirement that was conspicuous by its omission from the original 1990 deliberate release directive. The increased use of genetic modification techniques in food production created a difficulty for the EU legislator. Initial regulation was by way of framework directive. As objections to the use of this process became more prevalent, the legislation was found to be insufficient to deal with some of the complexities and sensitivities surrounding health protection, informing consumers and ethical considerations. This was particularly clear in relation to the shortcomings in the rules controlling the labelling of these products. Some types of genetically modified food escaped these requirements due to loopholes in the law, while others did not have to display this information in a prominent position on the label—contrary to increased demands for full disclosure of the techniques used in the production of food. This situation has improved with the introduction of a new regulatory regime for genetically modified foods. The increased use of directly applicable regulations rather than discretionary directives should assist in ameliorating the difficulties presented for free movement by the arbitrary application of the rules by individual Member States. The increased prominence of information on the label, and its more explicit disclosures, should also go some way to protecting consumers who wish to avoid these foodstuffs. However, it remains the case that food containing the meat, eggs or dairy produce from animals fed on a genetically modified diet need not reveal this fact.80 7.3 ALTERING CONSUMER PREFERENCES: THE DEMAND FOR ORGANIC FOOD

The various scares, coupled with concerns about the contamination of foodstuffs and an increase in the ethical considerations of consumers when purchasing food, have led to an increased demand for food that has been produced by organic methods. Global sales of organic food stood at €25 billion in 2005. Retail sales of organic produce in the United Kingdom alone exceed £1.6 billion, an increase of 30 per cent on 2004. This included sales of nearly 9,000,000 organically reared birds and two hundred million litres of milk. Nearly two-thirds of all consumers in the UK buy organic foods.81 The rules on the production and marketing of organic food in the European 79

Article 4(1). For further discussion see C MacMaoláin, ‘The New Genetically Modified Food Labelling Requirements: Finally a Lasting Solution?’ (2003) 28 European Law Review 865. 81 Organic Market Report 2006, published by the Soil Association. 82 Council Regulation (EEC) No 2092/1991 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [1991] OJ 80

(H) MacMaolin Ch7

9/2/07

15:17

Page 255

7.3 The Demand for Organic Food 255 Union are set out in Regulation 2092/91 and its many amendments.82 The regulation covers all products that claim themselves, generally by an indication on the labelling or advertising, to be produced organically, including both unprocessed agricultural animal and crop products and products containing organically produced ingredients.83 Food product labels may only refer to organic production methods where the product has been produced in accordance with the procedure laid down in the regulation.84 Under the regulation, products that are not entirely unprocessed may be labelled as organic where at least 95 per cent of the ingredients of agricultural origin contained therein are obtained by organic farming methods.85 Under an amending regulation, which came into operation in 1995, products may bear indications referring to organic production methods where at least 70 per cent of the ingredients of agricultural origin are, or are derived from, products obtained organically.86 These foodstuffs may be labelled as being ‘X% organically produced’.87

7.3.1 Organic Production Rules Most of the rules for the production of organic food are set out in the Annexes to Regulation 2092/1991. Annex I prescribes that a conversion period leading up to the production of organic food must generally have taken place for at least two years before the crops can be considered as having been organically produced. The fertility of the soil in which the crops are grown can only be increased or maintained by cultivating legumes, green manures or deep-rooting plants as part of a multi-annual rotation programme or by the incorporation of organic material into the soil. Livestock manure may be used if it comes from organically reared animals. Other fertilisers may only be used where these methods do not provide enough nutrients for the soil to grow the organic crops. Pests, diseases and weeds may only be controlled by a combination of permitted measures, such as appropriate rotation programmes, mechanical cultivation procedures, flame weeding, or protecting the L 198/1. Regulation 2092/1991 was first amended by Commission Regulation (EEC) No 1535/1992 of 15 June 1992 amending Annexes I and III of Council Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [1992] OJ L 162/15. The Regulation has been amended on 39 further occasions between this and the introduction of Commission Regulation (EC) No 780/2006 of 24 May 2006 amending Annex VI to Council Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [2006] OJ L 137/9. As at 21 July 2006, a further nine amendments have been proposed, including a proposal to repeal and replace the Regulation 2092/1991 regime. See Proposal for a Council Regulation on organic production and labelling of organic products. COM (2005) 671. 83 Article 1(1). 84 Article 5(1). 85 Article 5. 86 Council Regulation (EC) No 1935/1995 of 22 June 1995 amending Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [1995] OJ L 186/1. 87 Article 1.

(H) MacMaolin Ch7

9/2/07

15:17

Page 256

256 Contemporary Considerations for EU Food Law natural enemies of pests by providing them with nests or hedges. It is only where there is an immediate threat to the crop that recourse may be had to the list of these permitted fertilisers and/or pest controllers listed in Annex II to the regulation. Annex III to the regulation prescribes that farms producing organic crops must clearly keep cultivation, production and storage locations separate from any parts of the operation not producing organic products.88 Farmers must maintain written records for inspection which provide details of the origin, nature and quantities of all raw materials bought and the use to which they are put, as well as accounts of all such products sold. Inspections of organic operations, be they farms or factories, must take place on an annual basis. Unannounced inspection visits may also be made. All facilities used for the production of organic food must be made fully accessible to inspectors, as must samples of packaging and labelling used, or any other information deemed necessary for the purposes of the inspection. In particular, organic food must be proved to be transported to other operators, including wholesalers and retailers, in appropriate packaging, containers or vehicles. Similarly, storage must be managed in such a way that any mixing with or contamination by other non-organic products is avoided. Member States are charged with the establishment and operation of inspection systems to ensure that the terms of the regulation are complied with.89 7.3.2 Organic Livestock Production Annex I to Regulation 2092/1991 is amended by Regulation 1804/1999 to include a lengthy section on rules and standards for the production of livestock and livestock products, replacing the single paragraph dedicated to this which appeared in the original organic foods regulation.90 Originally, the only reference to livestock in the principles of farm-level organic production was to the use of by-products, such as farmyard manure, in the fertilisation of soil, stating that they could be used in accordance with existing national rules or, if none existed, internationally recognised standards. The new Annex I, Part B sets out detailed rules on conversion periods, animal origin, animal feed, veterinary treatment, husbandry management practices, animal welfare and manure use that must be complied with before the description ‘organic’ can be applied to food products derived from a range of animals, including cows, pigs, sheep, goats, horses, poultry and bees. The rules relating to organic livestock do not refer only to those animals that are to be slaughtered for meat or those which are kept to provide milk or eggs—they also cover animals kept on farms cultivating organic crops. Livestock not reared in 88 As amended by Commission Regulation (EC) No 2491/2001 of 19 December 2001 amending Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [2002] OJ L 337/9. 89 Article 9. 90 Council Regulation (EC) No 1804/1999 of 19 July 1999 Supplementing Regulation No 2092/1991 on organic production of agricultural products and foodstuffs to include livestock production [199] OJ L 222/1.

(H) MacMaolin Ch7

9/2/07

15:17

Page 257

7.3 The Demand for Organic Food 257 accordance with these provisions may be present on such farms, but where this is the case they must be kept entirely separate from those areas where organic production takes place. If livestock is to be sold as an organic product it must first have been reared according to set standards for a minimum of 12 months for horses and cattle used for meat production, six months for pigs and animals used for milk production and 10 weeks for poultry for meat production, provided the birds were brought in before they were three days old, and six weeks for poultry for egg production. Breeds or strains of animal are to be chosen with a view to avoiding specific diseases or health problems that may be associated with some breeds or strains used in intensive production, such as porcine stress syndrome, spontaneous abortion or those which often require caesarean operations due to difficult births. Preference is also to be given to indigenous breeds and strains. Livestock introduced to farms undergoing a process of conversion to organic farming methods must be introduced from organic sources. By way of derogation from this, a maximum of 10 per cent of female adult horses or cattle livestock and 20 per cent of female adult pigs, goats and sheep may be introduced from non-organic sources to supplement the growth or renewal of a herd or flock when organically reared animals are not available. Use of this derogation requires prior authorisation from the competent authority charged with overseeing the implementation of the provisions of the organic food regulations. Non-organic male animals for breeding may be introduced provided that they are subsequently reared and always fed in accordance with the provisions of the regulation. Under the terms of the new Annex IB, force feeding of livestock is prohibited. Livestock may only be fed on organically produced animal feed. The feeding of young mammals is to be based on natural milk, preferably that of the mother, for a minimum of three months for cattle and horses, 45 days for sheep and goats and 40 days for pigs. Roughage must be added to the daily diet of all organically reared animals at set levels.91 The feed formula used in the fattening stage for poultry must contain at least 65 per cent cereals. The use of conventional animal feed is to be kept to a minimum and limited to permitted exceptions. However, conventional feed should not be used at all where a sufficient level of similar organic animal feed exists in the EU. Animal feed, feed materials, compound feed, feed additives, processing aids for animal feed and certain products used in animal nutrition must not have been produced using gmos or products derived therefrom. Similarly, antibiotics and growth promoters may not be used in the production of organic livestock. One of the key principles underlying the rules on the production of organic livestock is that disease should be prevented, rather than cured by the use of veterinary medicines. For example, it is hoped that by carefully selecting generally indigenous 91 For example, at least 60 per cent of the dry matter in daily rations for herbivores is to consist of roughage, fresh or dried fodder, or silage. Roughage, fresh or dried fodder or silage must also be added to the daily ration for pigs and poultry.

(H) MacMaolin Ch7

9/2/07

15:17

Page 258

258 Contemporary Considerations for EU Food Law breeds, ensuring that they will be comfortable in their environment, adopting animal husbandry practices that encourage resistance to disease, using only high quality feed and ensuring the animals receive regular exercise, and ensuring that density levels are set to avoid overstocking, disease amongst organically reared animals will be reduced. Any animals that do become sick or injured are to be treated immediately in suitable housing, and in isolation if necessary. Where it is deemed necessary to use veterinary medicines these should, where possible, be phytotherapeutic (eg plant extracts) or homeopathic or products appearing in the positive list set out in the regulation.92 It is perhaps surprising that the legislation refers to these forms of treatment, given that their effectiveness in treating illness is highly contested.93 Chemical substances or antibiotics may only be used where other permitted treatments are, or are likely to be, unsuccessful and this is absolutely necessary to avoid causing suffering or distress to the animal. The use of chemically synthesised allopathic veterinary medicinal products or antibiotics for preventive treatment is always prohibited. Where veterinary medicinal products are to be used, the type of product must be recorded together with details of the diagnosis, the dose administered, the method of administration, the duration of the treatment, and the legal withdrawal period. The manufacture of organically produced food from such animals is not permitted until at least 48 hours after the last administration of a veterinary medicinal product. This period may be longer, depending on the type of medicine used. In principle, the reproduction of organically reared livestock should be based on natural methods. However, artificial insemination is permitted, but other forms of artificial or assisted reproduction, such as embryo transfers, are prohibited. Operations such as attaching elastic bands to the tails of sheep, tail-docking, cutting of teeth, trimming of beaks and dehorning must not be carried out systematically in organic farming. They may only occur where specifically authorised by the competent authority in the Member State for safety reasons, or if necessary to improve the health, welfare or hygiene of the livestock. Castration is permitted to maintain product quality or to preserve traditional production practices. Tethering of livestock is prohibited, unless specifically authorised or where neces92 Annex II, Part C, section 3 thereof. For discussion on the usefulness of homeopathic treatments in veterinary medicine see L Hektoen et al, ‘Comparison of Homeopathy, Placebo and Antibiotic Treatment of Clinical Mastitis in Dairy Cows—Methodological Issues and Results from a Randomised-clinical Trial’ (2004) 51 Journal of Veterinary Medicine 439; FC Velkers et al, ‘Isopathic and Pluralist Homeopathic Treatment of Commercial Broilers with Experimentally Induced Colibacillosis’ (2005) 78 Research in Veterinary Science 77. 93 The practice of homeopathic medicine was founded by Samuel Hahnemann (1755–1843). Homeopathy is based on the doctrine that diseases can be cured by administering minute doses of drugs which in larger amounts cause the very symptoms it is desired to alleviate. Though large and various claims are made by adherents of this system, and though its evaluation is beyond the scope of this work, there appears to be insufficient scientific evidence to warrant the assumption that all such claims made for this system are valid. For a summary of the scepticism that surrounds the use of homeopathy see P Skrabanek and J McCormick, Follies and Fallacies in Medicine 3rd edn (Whithorn, Tarragon Press, 1998), 121–5; L Hektoen, ‘Review of the Current Involvement of Homeopathy in Veterinary Practice and Research’ (2005) 157 The Veterinary Record 224.

(H) MacMaolin Ch7

9/2/07

15:17

Page 259

7.3 The Demand for Organic Food 259 sary for safety or welfare reasons. All these practices, where permitted, are to be carried out in a manner that minimises any suffering caused to the animal. Where livestock are reared in groups, the size of the group must depend upon their stage of development and the behavioural needs of the species concerned. Minimum ages for the slaughter of organic poultry are also set. For example, chickens must be at least 81 days old; peking ducks at least 49 days; and turkeys 140 days. Food derived from animals claimed to be produced organically must be transported in a manner that limits stress, in accordance with other Community or national legislation. Loading and unloading must be carried out without the use of electrical stimulation to coerce the animals. The use of allopathic tranquillisers, prior to and during transportation, is prohibited. Animals are to be treated in a stress-minimising manner in the period leading up to slaughter. Housing conditions for organic livestock must meet the animals’ biological and ethological needs (eg behavioural needs as regards freedom of movement and comfort). The livestock must have easy access to food and water. Insulation, heating and ventilation of the building must ensure that air circulation, dust levels, temperature, relative air humidity and gas concentration levels are kept within limits which are not harmful to the animals. The building must allow plentiful natural ventilation and light to enter. Free-range, open-air exercise areas, or openair runs must provide sufficient protection against rain, wind, sun and extreme temperatures if necessary, depending on the local weather conditions and the breed concerned. However, housing for livestock is not necessary, under the terms of the regulation, in areas where appropriate climatic conditions enable animals to live outdoors. The stocking density levels in buildings must ensure the well-being of the animals concerned, taking account of their behavioural needs. As a minimum, there must be enough space for the animals to stand naturally, lie down easily, turn around, groom themselves, assume all natural postures and make all natural movements, such as stretching and wing-flapping. Minimum surface area measurements for this are set in Annex VIII to the regulation. All housing is to be kept clean, to prevent cross-infection and disease. All mammals must have access to pasturage or an open-air exercise area whenever conditions, such as the health of the animals and the weather, allow. However, the final fattening phase of cattle, pigs and sheep for meat production may take place indoors, provided that this period does not exceed one-fifth of their lifetime or a maximum period of three months. At least half of the floor area of such housing must be solid, that is not slatted or of grid construction. Ample dry bedding must be provided. The terms of Directive 1991/629, laying down minimum standards for the protection of calves,94 and Directive 1991/630, laying down minimum standards for the protection of pigs,95 must also be complied with. 94 Council Directive 1991/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves. [1991] OJ L 340/28. 95 Council Directive 1991/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs. [1991] OJ L 340/33.

(H) MacMaolin Ch7

9/2/07

15:17

Page 260

260 Contemporary Considerations for EU Food Law Organic poultry must be reared in open-range conditions. They must not be kept in cages. Waterfowl must have access to a stream, pond or lake whenever weather conditions permit. Housing for poultry must meet minimum standards on flooring, cleanliness, perches and exit/entry pop-holes. Poultry houses may not contain more than 4,800 chickens, 3,000 laying hens, 5,200 guinea fowl, 4,000 female or 3,200 male peking ducks or 2,500 geese or turkeys. In the case of laying hens, natural light may be supplemented by artificial light to provide a maximum of 16 hours of light per day, with a continuous rest period without artificial light of at least eight hours. Poultry must have access to open-air runs and feeding and water troughs whenever weather conditions permit and, whenever possible, for at least one-third of their lives. Some derogation from the detail of these provisions is allowed within the Member States until 2010, but only where animal housing was constructed prior to 1999 and had complied with national provisions concerning organic livestock production in force prior to that date, or in the absence of such rules, comply with private standards accepted or recognised by the Member States, such as those of the Soil Association.

7.3.3 Genetic Modification and Organic Food The organic food regulations did not initially prohibit the use of genetic modification processes in the production of organic food. This was later certified in the decision in Parliament v Commission,96 where the applicant institution brought an action seeking the annulment of a 1993 Commission Regulation, which amended the framework regulation on organic foodstuffs.97 The Parliament sought the annulment of the contested legislation due to the fact that it included genetically modified micro-organisms in the list of ingredients of non-agricultural origin that may be present in foodstuffs that could be labelled and advertised as organic.98 It was claimed that the Commission had exceeded its powers, and undermined the objectives of the framework regulation insofar as it related to consumer expectations, the free movement of organic foodstuffs and the balance between agricultural production and protection of the environment. The Parliament also claimed that it should have been consulted on this amendment in accordance with the procedures set down in the Treaty.99 The Commission maintained that it was not obliged to consult with the Parliament on this issue because the regulation of gmos and micro-organisms was governed by other provisions of Community law, including the original deliberate release directive.100 96

Case C-156/1993, European Parliament v Commission [1995] ECR I-2019. Commission Regulation (EEC) No 207/1993 of 29 January 1993 defining the content of Annex VI to Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs and laying down detailed rules for implementing the provisions of Article 5 (4) thereto. [1993] OJ L 25/5. 98 Annex I to Regulation 207/1993. 99 Article 37 EC. 100 Council Directive 1990/220. 97

(H) MacMaolin Ch7

9/2/07

15:17

Page 261

7.3 The Demand for Organic Food 261 The Commission insisted that the contested legislation was designed to ensure that consumers would be protected in the future when genetically modified food would become more commonplace. It also pointed out that the framework organic food regulation did not prohibit the use of either gmos or genetically modified micro-organisms in organic farming, despite the fact that the Parliament had suggested that an amendment be drafted to ensure that this would become the case. The framework regulation did not prevent the addition of genetically altered foods or their ingredients to the lists of authorised ingredients specified therein either. The Commission thus insisted that it was perfectly entitled to act in the contested manner. The Court of Justice found that the inclusion of genetically modified microorganisms in the list of permitted non-agricultural constituents was not in contravention of the provisions of the regulation. The Court stated that when the Council adopted the regulation it did not seek to prohibit the use of either gmos or genetically modified micro-organisms in organic farming, despite the proposed amendment suggested by the Parliament. Thus Community rules allowed products containing genetically modified ingredients to be labelled as organic.101 They also permitted genetic modification processes to be used in the production of organic foodstuffs. It was soon realised that genetic modification techniques were not wholly compatible with the production of organic food. In particular they could lead to a reduction in consumer confidence in the wholesomeness of organic food. Hence it was later decided to remedy this problem by introducing, in a regulation more generally designed to set the standards for organic livestock, a prohibition on the marketing of foods as organic where they have undergone any genetic modification process.102 Regulation 1804/1999 (the organic farming regulation) amends Article 5(3) of Regulation 2092/1991, adding that the labelling and advertising of food may only refer to organic production where the product has been made without the use of gmos and/or any products derived from such organisms. Regulation 1804/1999 makes it clear that gmos and products derived therefrom includes any substance which is either produced from or produced by gmos, but which does not contain gmos. The ‘use of gmos and gmo derivatives’ includes their use in foodstuffs, food ingredients (including additives and flavourings), processing aids (including extraction solvents), animal feed, compound feed, feed materials, feed additives, processing aids for animal feed, products used in animal nutrition, plant protection products, veterinary medicinal products, fertilisers, soil conditioners, seeds, vegetative reproductive material, and livestock. Article 13 of Regulation 2092/1991 is also amended. This now provides that 101 Regulation 2092/1991 initially allowed up to five per cent of the constituents of a foodstuff to be genetically modified yet the product could still be labelled as ‘organic’. Under the terms of Regulation 1935/1995 up to 30 per cent of the constituents could be genetically modified and the product could still be labelled as being ‘X% organically produced’. 102 Council Regulation (EC) No 1804/1999 of 19 July 1999 supplementing Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs to include livestock production. [1999] OJ L 222/1.

(H) MacMaolin Ch7

9/2/07

15:17

Page 262

262 Contemporary Considerations for EU Food Law implementation measures must be set according to scientific evidence or technical progress, applying the prohibition on the use of gmos and gmo derivatives with regard, in particular, to a de minimis threshold for unavoidable contamination that is not to be exceeded. 7.3.4 Coexistence of Genetically Modified Crops with Conventional and Organic Farming A Commission Recommendation of 2003 sets out guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming practices.103 The Preamble to the Recommendation commences with a statement that: No form of agriculture, be it conventional, organic or agriculture using genetically modified organisms (GMOs), should be excluded in the European Union.

This, it is claimed, aims primarily at ensuring that the existence of different agricultural production systems will provide a high degree of consumer choice. It will also give farmers a choice between conventional, organic and genetically modified crop production. However, it is recognised that there may be serious economic consequences if genetically modified and non-genetically modified crops are not managed in a manner that helps to avoid admixture between the two. These guidelines were thus developed to establish a set of Community principles for the development of national strategies that, if implemented, could best avoid the contamination of conventional and organic foodstuffs. The Commission makes it clear from the outset that this recommendation applies to the economic aspects associated with the admixture of genetically modified and non-genetically modified crops only. It does not concern itself here with the environmental or health aspects of the cultivation and marketing of genetically modified food. This is covered in the deliberate release directive of 2001, and now also the general gmo and the labelling and traceability regulations of 2003. The Commission also sees its role in this regard as being limited to the gathering and co-ordination of relevant information, offering advice and issuing guidelines to assist Member States in establishing best practices for coexistence. The way in which advice and guidelines are implemented will need to differ according to particular national or regional conditions. EU farmers work in widely diverse environments. The co-ordination of efforts across Member States is thus best achieved by a broad set of general principles on co-existence. This may be justified on the grounds of the variety that exists across the European Union in terms of farm and field sizes, production systems, crop rotations and cropping patterns, as well as natural conditions. These guidelines, issued in the form of a non-binding recommendation addressed to the Member States, cover the potential for cross-contam103 Commission Recommendation 2003/556/EC of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming. [2003] OJ L 189/36.

(H) MacMaolin Ch7

9/2/07

15:17

Page 263

7.3 The Demand for Organic Food 263 ination from agricultural crop production on the farm up to the first point of sale—from ‘seed to silo’. The Recommendation sets out a series of general principles that are to underpin national strategies for best ensuring the peaceful coexistence of genetically modified and conventional and organic crops. All such national strategies are to be based on transparency and stakeholder involvement in decision-making, basing decisions on sound science, building on existing segregation methods and practices, proportionality, differentiation between the different needs of different crop varieties and growing conditions such as climate and farm size, co-operation (especially between farmers), and effective monitoring and evaluation of measures taken. The Recommendation also states that there is no particular policy instrument that can be recommended to best ensure safe coexistence. Voluntary agreements, soft law approaches and legislation all have a role to play in the effective implementation, monitoring, evaluation and control of measures introduced. In devising a national strategy, Member States should take into account the level of coexistence to be achieved (ie single farms, neighbouring farms or farms within the same region but separated by some distance); In order to devise a national strategy, Member States should take into account the level of co-existence to be achieved (i.e. on single farms, on neighbouring farms or on farms within the same region but separated by some distance); the different types of adventitious mixture that can occur (such as pollen transfer between neighbouring fields, the mixing of crops during harvest and post-harvest operations), the transfer of seeds during transport and storage, or seeds remaining in the soil after harvest which produce new plants in successive years, which occurs more frequently in some crops, such as oilseed rape, than in others, such as maize, which is unlikely to survive frost; the labelling threshold values that are set by Community law that prescribe the maximum permitted adventitious levels of genetically modified organisms that may be present in a conventional or organic food without this requiring to be labelled; the types of crops at issue; and lastly the general growing conditions, such as farm size, climate, topography and the activity, behaviour and population size of pollinators. More specific advice is offered to Member States with regard to how their national strategies can best be devised and implemented. As a minimum, strategies should set guidelines on (i) growing conditions and distances between coexisting genetically modified and other crops; (ii) harvest and post-harvest field treatment; (iii) transportation and storage; (iv) voluntary agreements on farm cooperation; (v) establishment of notification and monitoring schemes, using the feedback obtained from this as a basis for further adjustment and refinement of national strategies; and (vi) keeping of records on management practices, cultivation processes and traceability. Member States should also encourage training courses for farmers on coexistence measures and implement conciliation procedures to solve cases of disagreement between neighbouring farmers concerning the implementation of measures for coexistence.

(H) MacMaolin Ch7

9/2/07

15:17

Page 264

264 Contemporary Considerations for EU Food Law 7.3.5 Future Regulation of Organic Production Three main difficulties have plagued EU attempts to regulate the production and marketing of organic food. First, the original regulation permitted the presence of genetically modified ingredients in organic food. Second, after a 1995 amendment it also enabled foods containing up to 30 per cent non-organic ingredients to be labelled as being ‘organically produced’, facilitating the deception of consumers into purchasing a food product not in compliance with generally recognised expectations about what constitutes organic food.104 Third, there has been a plethora of amendments to the organic foods regulation since its introduction in 1992. More than 40 amending regulations make it difficult for those who wish to produce and/or market organic food to work within the framework. This should be resolved, temporarily at least, by the introduction of a new, consolidating regulation on organic production and the labelling of organic products.105 The proposal for such a regulation prioritises consumer confidence in organic foods, primarily by reducing the possibility of producers using misleading labelling referring to organic production methods, protection of the environment, and setting high standards for animal welfare. The new regulation should also eradicate the first two difficulties with the original organic foods regulation that were identified above. The use of genetic modification in organic production continues to be prohibited, as it has been since 1999.106 Labelling products that are up to 30 per cent of non-organic origin as being organically produced is now also to be prohibited. All of this should go some way to making the labelling of organic foodstuffs more reliable. This is subject to the caveat that labelling may continue to be misleading in some circumstances. This became the case for example during the 2006 scare over avian influenza. Rules provided that meat and eggs could be marketed as organic even though the poultry used in their production were kept indoors.107 7.4 ETHICAL FOOD PRODUCTION

Consumers are increasingly interested in purchasing food that has been produced in specific ways. As discussed earlier, sales of organic food continue to increase significantly, and ethical concerns regarding the treatment of animals used for food production are similarly prevalent. Community legislation on welfare standards 104

Regulation 1935/1995. Proposal for a Council Regulation on organic production and labelling of organic products. COM (2005) 671. 106 Council Regulation (EC) No 1804/1999 of 19 July 1999 supplementing Regulation (EEC) No 2092/1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs to include livestock production. [1999] OJ L 222/1. 107 Commission Regulation (EC) No 699/2006 of 5 May 2006 amending Annex I to Council Regulation (EEC) No 2092/1991 as regards conditions of access for poultry to open-air runs. [2006] OJ L 121/36. For further discussion about what this can mean for the welfare standards of supposedly ‘free range’ and/or ‘organic’ birds see Chapter 8 of P Singer and J Mason, The Way We Eat: Why Our Food Choices Matter (Emmaus, PA, Rodale, 2006). 105

(H) MacMaolin Ch7

9/2/07

15:17

Page 265

7.4 Ethical Food Production 265 must thus ensure that where consumers are willing to pay a premium for products produced from animals that have been well treated, this additional cost reflects a real difference between these products and their conventional counterparts.

7.4.1 Animal Welfare Standards A series of legislative initiatives have been introduced at Community level to ensure that animals used in food production are well treated. In addition to standards relating to the production and subsequent labelling of organic foods, specific directives on the protection of calves, pigs and poultry also exist.

7.4.2 Community Legislation on the Protection of Calves and Pigs Directive 1991/629 sets minimum standards for the protection of calves.108 The preamble to the directive makes it quite clear that it was not introduced as a result of any real concerns about animal welfare protection; instead its main purpose was to ensure that differences in required standards of animal care between the Member States did not lead to a distortion in competition. If Member State A sets low standards for animal welfare protection in its national law but Member State B requires that animals reared for food production must be well housed, fed and spend some time outdoors, Member State A is able to produce food at a lower cost, distorting competition between the Member States. The temptation for a Member State to lower its welfare standards may even be encouraged by Community rules on the free movement of goods. If national products are open to competition from products produced elsewhere in the EU at a lower cost, the Member State may now seek to lower its own producers’ costs in order to meet this challenge. One of the easiest ways of achieving this is to reduce minimum welfare standards for animals used in food production. Calves, for the purposes of the directive, are bovine animals up to six months of age.109 The Directive sets minimum standards for the amount of floor space that each calf should get, with an allowance for the special conditions to be set for those calves that require it on account of their behaviour, the fact that they are purebred, or because they are kept with their mothers for suckling.110 Member States must carry out inspections to ensure that the provisions of the directive are complied with,111 and these may be supplemented by checks made by veterinary experts from the Commission.112 This strategy is designed primarily to ensure the 108 Council Directive 1991/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves. [1991] OJ L 340/28. 109 Article 2. 110 Article 3. 111 Article 7. 112 Article 9.

(H) MacMaolin Ch7

9/2/07

15:17

Page 266

266 Contemporary Considerations for EU Food Law uniform application of the directive across the Community. As with many of the directives in this area, the detailed rules are set out in the Annex, which provides that materials used to build calf housing must not be capable of being harmful to the animals in any way and must be capable of being thoroughly cleaned and disinfected. Insulation, heating and ventilation of such buildings must be designed to ensure that the calves are not harmed in any way. All automated or mechanical equipment must be inspected at least once daily, and defects must be rectified immediately. Calves must not be kept in permanent darkness—there must be natural or artificial lighting. If artificial lighting is used, it must be maintained for eight consecutive hours per day. Accommodation for calves must be sufficient for them to stand up, lie down, rest and groom without difficulty and they must be able to see other calves. Calf feed must contain suitable quantities of iron and fibre. Calves must not be muzzled, they must be fed at least once per day, and they must have access to a sufficient supply of water when they are over two weeks old. Finally, feeding and watering equipment must be designed, constructed, placed and maintained so that contamination of feed and water is kept to a minimum. Similar standards are set by Community law on the protection of pigs.113 The pig protection directive provides for a minimum unobstructed floor space for each pig, depending on its weight.114 Member States are charged with the responsibility of ensuring that inspections are carried out by the relevant competent authority, checking that the provisions of the directive and its Annex are complied with.115 They may, on occasions, be accompanied by veterinary experts from the Commission.116 Animals imported from non-member countries must, as far as welfare standards are concerned, have been reared to a standard at least equivalent to that set out in the pig protection directive.117 The Annex to the directive sets out a series of requirements relating to the construction of housing for pigs, the provision of lighting to ensure that they are not kept in darkness, daily inspections by farmers to ensure that they are healthy, preventing fighting amongst pigs, and the provision of a healthy diet. Chapter II of the Annex states that castration of pigs should only occur under anaesthetic by a veterinary surgeon and that tail-docking and toothclipping may only occur if necessary to prevent injury to other pigs. Tooth-clipping, where it is necessary, must be carried out within seven days of birth. 7.4.3 Health, Welfare and Consumer Protection: Production and Marketing of Poultry and Eggs Standards relating to the rearing and treatment of animals used for food production are designed not only to improve welfare, but also to protect scrupulous pro113 Council Directive 1991/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs. [1991] OJ L 340/33. 114 Article 3. 115 Article 7. 116 Article 9. 117 Article 8.

(H) MacMaolin Ch7

9/2/07

15:17

Page 267

7.4 Ethical Food Production 267 ducers and consumers. Labelling descriptions such as ‘free range’ and ‘organic’ should only be used where set minimum standards have been met, guaranteeing that the product is worthy of a premium price. Welfare Standards and Consumer Protection Three key pieces of secondary Community legislation determine legitimate use of the marketing description ‘free range’ as applied to eggs. These are Regulation 1907/1990 on marketing standards for eggs,118 Directive 1999/74 laying down minimum standards for the protection of laying hens,119 and Regulation 2295/2003 setting out more detailed rules on the implementation of Community marketing standards for eggs.120 This body of legislation presents clear rules on the marketing of eggs as ‘free range’ and the welfare standards that must be applied to laying hens involved in their production.121 It has not always been, and in many ways continues not to be, so straightforward. Previous rules in this area have exemplified much of that which is also problematic in relation to the marketing and advertising of food more generally in the EU. The first Community legislation on marketing standards for eggs to appear after free range eggs became popular actually made no reference to the term ‘free range’. Instead it dealt primarily with grading classes based on quality and weight.122 This regulation set three main classes for the marketing of eggs. Class A included all fresh eggs, Class B included all ‘second quality or preserved eggs’, while those eggs graded as Class C were ‘down-graded eggs intended for the food industry’.123 Such 118 Council Regulation (EEC) No 1907/1990 of 26 June 1990 on certain marketing standards for eggs. [1990] OJ L 173/5. This Regulation replaced, although not immediately, Regulation (EEC) No 2772/1975 of the Council of 29 October 1975 on marketing standards for eggs. [1975] OJ L 282/56. 119 Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens. [1999] OJ L 203/53. Whilst Directive 1999/74 does lay down general minimum standards for the protection of laying hens, no standards are set for therein for ‘free range’ production. Under the terms of the Directive those hens who have the misfortune of spending their lives in ‘unenriched cage systems’ must be provided with housing that is at least 40 cm high over 65 per cent of the cage, and not below 35 cm at any point. These cages should also be able to ‘support adequately each of the forward facing claws of each foot’ on a slope not exceeding 14 per cent (Article 5). The really good news, however, lies in the Annex, where it is stated that ‘without prejudice to the provisions of point 19 of the Annex to Directive 98/58/EC, all mutilation (with the exception of beak trimming where deemed necessary) shall be prohibited’. Point 19 of the Annex to Directive 1998/58/EC states: ‘Pending the adoption of specific provisions concerning mutilations in accordance with the procedure laid down in Article 5, and without prejudice to Directive 91/630/EEC, relevant national provisions shall apply in accordance with the general rules of the Treaty.’ Council Directive 1998/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes. [1998] OJ 221/23. 120 Commission Regulation (EC) No 2295/2003 of 23 December 2003 introducing detailed rules for implementing Council Regulation (EEC) No 1907/1990 on certain marketing standards for eggs. [2003] OJ L 340/16. 121 Community legislators have now recognised the importance of high welfare standards in the successful marketing of eggs. For example, the preamble to Council Regulation 5/2001 states that ‘[t]he method by which hens are farmed has become one of the major factors for consumers when purchasing eggs’. 122 Council Regulation (EEC) No 1907/1990 of 26 June 1990 on certain marketing standards for eggs. [1990] OJ L 173/5. 123 Article 6.

(H) MacMaolin Ch7

9/2/07

15:17

Page 268

268 Contemporary Considerations for EU Food Law a classification system gives cause for concern, given that practically all eggs of consumable quality fall within Class A, yet those eggs in the lowest quality category may still be used in the production of food. However, a year later, minimum standards for legitimate use of the marketing term ‘free range’ were introduced in Regulation 1274/1991, which set out, for the first time, more detailed rules on marketing standards for eggs.124 This regulation provided that eggs marketed as ‘free range’ must be produced from hens that have continuous daytime access to open-air runs; the ground to which hens have access must be mainly covered with vegetation; the maximum stocking density must not be greater than one hen per 10 metres square; and the interior of the building must satisfy minimum standards on floor covering, perches and cleanliness.125 This regulation was amended by Regulation 1651/2001,126 and has now been repealed by Regulation 2295/2003.127 Essentially, what resulted was a multitude of legislative measures, with little clarity on the important issues of consumer concern, fair trading and animal welfare and production rules. Regulation 1651/2001 did introduce a new Annex III to Regulation 1274/1991, but it was quite clear from the discordant and piecemeal nature of both the former amending regulation and the body of regulations arising out of Regulation 1907/1990, that by 2001 what was really required was a consolidating act. This new Annex III did categorise egg production methods into standards for free range eggs, barn eggs and eggs from caged hens, but establishing the true definition of any of these required substantial cross-referencing and checking of other pieces of secondary Community legislation, which themselves were subject to regular change and amendment, making clarification of the law difficult. Even now, Community legislation on this matter makes multiple references to criteria set out in already altered legislation. An act of consolidation is still required. Here, however, by sifting through the large body of relevant legal texts that together determine exactly what is meant in Community law by the term ‘free range’, we can narrow the focus down to the three key pieces of legislation specified at the beginning of this section.128 Regulation 2295/2003 sets a series of standards for the production, labelling, traceability and marketing of eggs.129 The characteristics defining Grade A and B eggs are set,130 as are the weights that determine whether an egg is considered 124 Commission Regulation (EEC) No 1274/1991 of 15 May 1991 introducing detailed rules for implementing Regulation (EEC) No 1907/1990 on certain marketing standards for eggs. [1991] OJ L 121/11. 125 Annex II to Regulation 1274/1991. 126 Commission Regulation (EC) No 1651/2001 of 14 August 2001 amending Regulation (EEC) No 1274/1991 introducing detailed rules for implementing Council Regulation (EEC) No 1907/1990 on certain marketing standards for eggs. [2001] OJ L 220/5. 127 Article 38. 128 Namely Regulation 1907/1990, Directive 1999/74 and Regulation 2295/2003. 129 Regulation 2295/2003 has since been amended by Commission Regulation (EC) No 1515/2004 of 26 August 2004 amending Regulation (EC) No 2295/2003 introducing detailed rules for implementing Council Regulation (EEC) No 1907/1990 on certain marketing standards for eggs. [2004] OJ L 278/7. 130 Articles 5 and 6.

(H) MacMaolin Ch7

9/2/07

15:17

Page 269

7.4 Ethical Food Production 269 small, medium, large or extra-large.131 There is no Grade C classification. There is to be an indication of the date of minimum durability, which should be not more than 28 days after laying.132 There should also be a ‘sell-by’ date stated on the label.133 An indication of the poultry-rearing method employed must also be stated on the label.134 The different methods that may be employed are set out in Annex III to the regulation. This list includes free range eggs, which must be produced in establishments satisfying the terms of Directive 1999/74. These enable the hens to have continuous daytime access to open-air runs that are mainly covered with vegetation and a set amount of room in which to move freely (one hen per four square metres). Barn eggs are also covered. These must be produced in establishments satisfying Article 4 of Directive 1999/74, which sets minimum standards for eating and drinking facilities for the birds as well as setting requirements on stocking density (no more than nine hens per square metre) and sanitation. Eggs from caged hens must be produced in establishments satisfying Article 5 of Directive 1999/74, including those on minimum cage sizes (550 square cm per hen, and at least 40 cm high over 65 per cent of the cage area). Alternatively, eggs may be labelled as ‘organic’ where they are produced in accordance with Regulation 2092/1991.135 All establishments producing eggs, under the terms of Regulation 2295/2003, must be inspected at least once a year.136 All Grade A eggs must now carry a code designating the producer’s distinguishing number and identifying the farming method used.137 The farming method aspect of this code consists of a number, 0, 1, 2 or 3 representing organic, free-range, barn and cage-reared respectively. The terms of the body of legislation regulating the production and marketing of eggs may, in some ways, lead to consumers being deceived. For example, Regulation 1907/1990 allows producers to include additional statements on the labelling that are designed to promote sales of their product, provided that they do not mislead the consumer.138 The most obvious examples are those relating to the production method, such as ‘free range’, or those relating to their quality. However, under the terms of Regulation 2295/2003 almost all eggs that are marketed to consumers are now Grade A, giving the producers of top-graded eggs no real marketing advantage. The decision of the Court of Justice in Springenheide and Tusky offers a good example of the type of evidence that can be presented in such circumstances to 131

Article 7(1). Article 9. 133 Article 11. 134 Article 13. 135 Article 13 of Regulation 2295/2003. For discussion on what can constitute ‘organic’ eggs in the USA see Singer and Mason, n 104 above, Chapter 8. 136 Article 24. 137 Article 7 of Regulation 1907/1990 as amended by Council Regulation (EC) No 5/2001 of 19 December 2000 amending Regulation (EEC) No 1907/1990 on certain marketing standards for eggs. [2001] OJ L 2/1. 138 Article 10(2)(e). 132

(H) MacMaolin Ch7

9/2/07

15:17

Page 270

270 Contemporary Considerations for EU Food Law determine whether this additional labelling information has the potential to deceive consumers.139 The case concerned proceedings brought against a German company which had been marketing its eggs with the description ‘six-grain—10 fresh eggs’, implying that the hens producing the eggs had been fed on a diet of six varieties of cereal. A slip of paper enclosed in each pack of eggs extolled the beneficial effects of this feed on the quality of the eggs. However, they were ordered to remove this additional labelling and the director of the company was fined by the state authorities, due to the fact that only 60 per cent of the feed given to the hens consisted of the six grain types. This judgment was unsuccessfully appealed before the state administrative court, where it was considered that the description and the pack insert infringed Article 10 of Regulation 1907/1990, as they were likely to mislead a significant proportion of consumers because they implied falsely that the feed given to the hens consisted exclusively of the six cereals indicated. This was appealed on a point of law before the federal administrative court. It was argued that the description and the pack insert actually provided the consumer with vital information and that the appeal court had not been provided with any expert opinion to prove that the purchaser was being misled in any way. During those proceedings, the Court of Justice was asked whether, in assessing whether statements designed to promote sales are likely to mislead the purchaser, the actual expectations of the consumer to whom the statement is addressed should be determined. If so, should this be based on an examination of the expectations of the informed average consumer, or of the casual consumer? How should such consumer groups be identified and what measures should be used to ensure that their expectations have been met? The referring court essentially asked for a definition of the concept of ‘consumer’ to be used as a standard for determining whether a statement designed to promote sales would be likely to mislead the purchaser. The Court examined other, more general, existing secondary Community legislation to assist it in ascertaining a Community concept of ‘consumer’. In particular, Directive 1979/112 on food labelling140 and Directive 1984/450 on misleading advertising141 were scrutinised. The misleading advertising directive prescribes that misleading advertising means any advertising which in any way, including its presentation, deceives or is likely to deceive the persons to whom it is addressed or whom it reaches, and which by reason of its deceptive nature is likely to affect their economic behaviour.140 In previous cases the Court had considered the presumed expectations of the average consumer, who was deemed to be rea-

139 Case C-210/1996, Gut Springenheide GmbH and Rudolf Tusky v Oberkreisdirektor des Kreises Steinfurt—Amt für Lebensmittelüberwachung [1998] ECR I-4657. 140 Council Directive 1979/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer. [1979] OJ L 33/1. 141 Council Directive 1984/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising. [1984] OJ L 250/17. 142 Article 2(2).

(H) MacMaolin Ch7

9/2/07

15:17

Page 271

7.4 Ethical Food Production 271 sonably well-informed and reasonably observant and circumspect.143 It was not thought necessary to order an expert report or to commission a consumer research poll on the matter at issue.144 It was felt that national courts should be able to assess any misleading effect of a description or statement designed to promote sales on the same basis. However, it was also noted that in cases where the evidence and information before the Court is not sufficient or clear, then it will be for the national court to determine whether the description or statement was misleading on the basis of its own conditions, leaving open the possibility of conducting a consumer survey or seeking expert opinion on the matter.145 It would thus be for the national court in a case such as this, where no specific Community provision exists, to determine, by whatever means it chooses, whether the percentage of consumers misled by a promotional statement would be sufficiently significant to justify banning its use. Such an assessment must be based on the presumed expectations of reasonably well-informed, observant and circumspect consumers. Hygiene Standards for Egg Production Directive 1989/437 lays down hygiene and health requirements concerning the production and the placing on the market of egg products for direct human consumption or for the manufacture of foodstuffs.146 Egg products are: products obtained from eggs, their various components or mixtures thereof, after the removal of the shell and membranes, intended for human consumption; they may be partially supplemented by other foodstuffs or additives; they may be liquid, concentrated, dried, crystallised, frozen, quick-frozen or coagulated.147

Member States must ensure that only egg products that meet certain general requirements are produced as foodstuffs or are used in the manufacture of foodstuffs. The products must have been obtained from the eggs of hens, ducks, geese,

143 See, for example, Case C-239/2002, Douwe Egberts NV v Westrom Pharma NV and Christophe Souranis [2004] ECR I-7007, para 46; Joined Cases C-421/2000, C-426/2000 and C-16/2001, Renate Sterbenz and Paul Dieter Haug [2003] ECR I-1065, para 43; Case C-465/1998, Verein gegen Unwesen in Handel und Gewerbe Köln eV v Adolf Darbo AG [2000] ECR I-2297, para 20. 144 See, for example, Case C-362/1988, GB-INNO-BM v Confédération du commerce luxembourgeois [1990] ECR I-667; Case C-238/1989, Pall Corp v Dahlhausen & Co [1990] ECR I-4827; Case C-126/1991, Schutzverband gegen Unwesen in der Wirtschaft eV v Yves Rocher GmbH [1993] ECR I-2361; Case C-315/1992, Verband Sozialer Wettbewerb eV v Clinique Laboratoires SNC et Estée Lauder Cosmetics GmbH [1994] ECR I-317; Case C-456/1993, Zentrale zur Bekämpfung unlauteren Wettbewerbs eV v Privatkellerei Franz Wilhelm Langguth Erben GmbH & Co KG [1995] ECR I-1737; Case C-470/1993, Verein gegen Unwesen in Handel und Gewerbe Köln eV v Mars GmbH [1995] ECR I-1923. 145 Case 94/1982, Criminal proceedings against De Kikvorsch Groothandel-Import-Export BV [1983] ECR 947; Case C-313/1994, Graffione SNC v Ditta Fransa [1996] ECR I-6039; Case C-210/1996, Gut Springenheide GmbH and Rudolf Tusky v Oberkreisdirektor des Kreises Steinfurt—Amt für Lebensmittelüberwachung [1998] ECR I-4657. 146 Council Directive 1989/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products. [1989] OJ L 212/87. 147 Article 2(1).

(H) MacMaolin Ch7

9/2/07

15:17

Page 272

272 Contemporary Considerations for EU Food Law turkeys, guinea fowl or quail, but they may not contain a mixture of eggs of different species. The products must bear an indication of the percentage of egg ingredients they contain when they are partially supplemented by other foodstuffs or additives. They must also have been treated and prepared in an establishment approved under the terms of the directive and in conformity with the hygiene conditions set out therein.148 Small-scale enterprises, shops and restaurants are excluded from the scope of the directive where their egg products are used for the manufacture of foodstuffs intended for direct sale to the final consumer or which are to be consumed immediately after being prepared.149 Staff who treat or handle eggs and egg products must, in particular, wear clean working clothes and headgear, wash and disinfect their hands several times in the course of each working day and whenever they return to their workstation after a break. Smoking, eating, spitting and chewing must all be prohibited in areas where the products are being handled and stored. Animals should not enter establishments where production is taking place. The premises, equipment and instruments used in the production of egg products must be kept clean and in a good state of repair, and if necessary cleaned and disinfected several times during the working day, and they should be used for no purpose other than the processing of egg products.150 Member States have various responsibilities under the directive. They must ensure that checks are carried out to detect traces of substances such as pesticides, antibiotics or detergents whose presence in egg products may be dangerous or harmful to human health.151 They must also draw up lists of approved establishments, each of which should be given an approval number.152 In order to become an approved establishment, assurances must be given to the effect that the terms of the directive will be complied with.153 The establishment must have suitable rooms that are large enough for the separate storage of eggs and the finished egg products—with appropriate refrigeration equipment where necessary, there must be facilities for washing and disinfecting eggs, there must be a room for the storage of other foodstuffs and additives, there must be suitable equipment for the hygienic packaging of egg products, and special conditions apply where egg products are to be pasteurised.154 Member States are obliged to relinquish approval if the conditions for granting it cease to be fulfilled.155 The directive does recognise that it is the primary responsibility of producers to ensure that egg products meet the health requirements laid down but that the competent authorities of the 148

Article 3. Article 1. 150 Annex to Council Directive 1989/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products. [1989] OJ L 212/87. 151 Article 5. 152 Article 6(1). 153 Article 6(1). 154 Annex to Council Directive 1989/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products. [1989] OJ L 212/87. 155 Article 6. 149

(H) MacMaolin Ch7

9/2/07

15:17

Page 273

7.4 Ethical Food Production 273 Member States must, by carrying out checks and inspections, ensure that producers comply with the requirements.156 Poultry Production Regulation 1906/1990 sets out a series of definitions and standards for the grading and marketing condition of poultry meat.157 Regulation 1538/1991 was later introduced to flesh out the framework set in the poultry meat marketing regulation.158 It provides a series of additional statements that may appear alongside the sales name, indicating the method by which the poultry was produced, such as ‘fed with’, ‘barn reared’ or ‘free range’.159 Use of these terms is further qualified in Annex IV to the regulation, which provides that ‘barn reared’ poultry must be housed in an area where the stocking rate does not exceed 12 birds (or 25 kg of birds) per square metre of floor space, and that birds must not be slaughtered at less than 56 days for chickens, 70 days for turkeys and 49 days for peking ducks. The term ‘free range’ may only be used where, during at lest half of their lifetime, the birds have had continuous daytime access to open-air runs in an area of vegetation of not less than one square metre per chicken, two square metres per duck and four square metres per turkey or goose. In addition to this, free-range poultry must be fed on at least 70 per cent cereals during their fattening stage. The term ‘traditional free range’ may be used where the birds have had continuous daytime access to open-air runs from the age of six weeks for chickens or eight weeks for ducks, geese and turkeys, providing two square metres for each chicken or duck, six square metres per turkey or 10 square metres per goose. The minimum age of slaughter for these birds is 81 days for chickens and 140 days for turkeys (unless they are intended for cutting up, in which case this reduces to 98 days for female turkeys and 126 days for male turkeys)160 and geese, except for geese intended for foie gras production, which may be slaughtered at 102 days. The phrase ‘free range—total freedom’ may be used to describe poultry which has been reared in the same manner as traditional free range poultry, but where the run to which they have access is unlimited in size. Regulation 1538/1991 has now been amended to include a provision requiring that geese and ducks used for the production of foie

156 Preamble to Council Directive 1989/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products. [1989] OJ L 212. 157 Council Regulation (EEC) No 1906/1990 on certain marketing standards for poultry. [1990] OJ L 173/1. 158 Commission Regulation (EEC) No 1538/1991 of 5 June 1991 introducing detailed rules for implementing Regulation (EEC) No 1906/1990 on certain marketing standards for poultry. [1991] OJ L 143/11. 159 Article 10. 160 As amended by Commission Regulation (EC) No 1321/2002 of 22 July 2002 amending Regulation (EEC) No 1538/1991 introducing detailed rules for implementing Council Regulation (EEC) No 1906/1990 on certain marketing standards for poultrymeat. [2002] OJ L 194/17.

(H) MacMaolin Ch7

9/2/07

15:17

Page 274

274 Contemporary Considerations for EU Food Law gras may no longer be labelled as ‘free range’ unless a statement is included which indicates that they have been used for the production of foie gras.161 While there are detailed rules at Community level for the production and marketing of poultry and eggs, they do not always satisfy the dual aim of protecting consumers and human health. The ethically aware consumer who wishes to purchase organic or free range meat is conceivably unaware that the animals used in its production may legally have spent a large portion of their lives indoors. In some circumstances, poultry can be labelled as organic even where the bird used to produce it never ventured outdoors, provided that it had access to sufficient quantities of roughage and suitable material in order to meet its ethological needs.162 Regulations on disease also tend to put free movement first, with consumer protection and human health considerations trailing behind. Measures enacted to control salmonella, for example, make it very difficult for Member States to prohibit the importation of eggs from other Member States where there is a high risk of contamination.163 Free movement policies dictate the content of EU food law. While other considerations are accounted for, the functioning of the internal market is considered to take priority.164 7.5 CONCLUSION

Many food products that are manufactured in the European Union are high quality, wholesome and produced by ethical methods. Equally, many are of poor quality, lacking in nutritional value and produced in a highly questionable manner. Many are safe, many are dangerous. Some arrive at our breakfast bars, office desks and dinner tables containing a mixture of good and bad properties. The EU has played a major role in determining the acceptability of both the positive and negative aspects of food production. The consumer has also had a key part to play in this. Recent history suggests that it is only where consumer unrest surfaces that issues of concern will be addressed. Where such lobbying fails to materialise, matters of huge importance to the health and welfare of humans, animals and the environment are overlooked, or are paid lip-service at best. This has been evident throughout the development of EU food law and policy, and it continues to be the case. If the issues discussed in this book are examined in general terms, a clear pattern of action and inaction in relation to certain important aspects of the production and marketing of food can be identified. The manner in which rules and 161 Commission Regulation (EC) No 1321/2002 of 22 July 2002 amending Regulation (EEC) No 1538/1991 introducing detailed rules for implementing Council Regulation (EEC) No 1906/1990 on certain marketing standards for poultrymeat. [2002] OJ L 194/17. 162 Commission Regulation (EC) No 699/2006 of 5 May 2006 amending Annex I to Council Regulation (EEC) No 2092/1991 as regards conditions of access for poultry to open-air runs. [2006] OJ L 121/36. 163 Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specific food-borne zoonotic agents. [2003] OJ L 325/1. 164 See also Chapter 5 of I Ward, A Critical Introduction to European Law 2nd edn (London, LexisNexis, 2003).

(H) MacMaolin Ch7

9/2/07

15:17

Page 275

7.5 Conclusion 275 principles on the free movement of food have developed raises a number of issues about the operations of the ‘common market’. EU law allows national producers to be discriminated against in their own Member State. Provided that importers are not disadvantaged in any way, there is no contravention of free movement rules. The ‘common market’ is not a market of equals. The jurisprudence of the Court of Justice also provides that Member States can not prescribe the use of different food names for different food products, unless there is a ‘substantial difference’ between them. The test of difference remains arbitrary and unclear. Additional labelling informing the consumer about the nature of the product is a more proportionate response where differences do exist. However, requiring that the labels of imported foods be altered prior to marketing is deemed disproportionate to the aim pursued. Because of this it is assumed that consumers will read labels and ingredient listings, will be aware about the nature of traditional foodstuffs produced throughout the twenty-five Member States, will all have a preference for fully cooked hard-boiled eggs and will understand what the 400 or so ‘e’ numbers used in additive listings stand for. This type of reasoning has led to justifications that foods containing as little as 70 per cent meat should be labelled as ‘meat products’, regardless of what the other 30 per cent is made up of, and that substitute versions of products should be marketed as if they are the original version, bearing the same name. The Court has repeatedly stated that consumer tastes in the different Member States will evolve over time, and that consumer habits should not be crystallised by national laws that inhibit free movement in any way. The common market will create a standardised consumer. This is despite the fact that the evidence suggests that the more food markets are globalised, the more consumers revert to the ‘country of origin effect’—preferring domestically produced goods over imported ones. Of most concern is the fact that EU rules on free movement, despite the existence of an explicit Treaty provision allowing Member States to take action to protect human health, effectively bar Member States from intervening in human habits that are contributing to the obesity crisis. It is only where a clear danger to human health exists, posed by disease or contamination, that Member States may use this exception to justify national measures that impede free movement. Where Community rules exist, such as those on nutrition labelling, Member States cannot take their own interventionist action to protect this ‘average consumer’ from himself or herself. Conversely, the Member States have more control over the type of measures that they can adopt in the interests of health protection where the EU has failed to introduce related harmonising measures. The shortcomings of this situation have been recognised by the Community institutions. Nevertheless, the decision has been taken to rely on this jurisprudence to facilitate free movement through the principle of mutual recognition, rather than to develop common food standards, setting minimum compositional requirements across the EU which would increase consumer protection and quality levels, and enhance human health and free movement. It is claimed that the

(H) MacMaolin Ch7

9/2/07

15:17

Page 276

276 Contemporary Considerations for EU Food Law approach advocated here would put food production in a legislative straitjacket. This does not have to be the case. Rather than setting detailed compositional standards for all foodstuffs, a series of simple minimum requirements for the more common generic foodstuffs could be created—similar to the approach advocated in the Commission Communication on Better Regulation.165 Requiring that meat products contain meat, milk contains milk and alcoholic drinks contain alcohol should not prove overly-inhibitive to food industry innovators. The European Union is able to address all these shortcomings by modifying some existing rules, and by applying others properly. For example, Regulation 2826/2000 enables the Community to finance, wholly or in part, actions of information and promotion in respect of agricultural and food products and their method of production.166 This can include public relations work, promotion and advertising which draws attention to intrinsic features and advantages of Community products, in particular the quality and safety of food, specific production methods, nutritional and health value, labelling, high animal welfare standards and respect for the environment.167 Special provision is also made for raising awareness of Community systems on protected designations of origin and protected geographical indications, organic production and food labelling requirements. In 2002 the Commission introduced more detailed rules for the implementation of this scheme,168 listing those products that may be subject to the promotion measures, including milk products, quality wines or table wines with a geographical indication and fruit and vegetables, both fresh and processed.169 Indicative amounts of support that should be made available to finance such campaigns are set at €4 million for protected designations of origin and protected geographical indications and €6 million for each of organic food, milk and milk products, wine and fresh fruit vegetables, with €3 million for processed fruit and vegetables.170 Support for the promotion of eggs was added to the list in 2004.171 However, this support was to be aimed at informing consumers how they could decipher the senseless (as far as their worth to consumers is concerned) Community egg code that must appear on all such products since January 2004.172 165 Communication from the Commission to the Council and the European Parliament: Better Regulation for Growth and Jobs in the European Union. COM (2005) 97. 166 Council Regulation (EC) No 2826/2000 of 19 December 2000 on information and promotion actions for agricultural products on the internal market. [2000] OJ L 382/2. Article 1. 167 Article 2. 168 Commission Regulation (EC) No 94/2002 of 18 January 2002 laying down detailed rules for applying Council Regulation (EC) No 2826/2000 on information and promotion actions for agricultural products on the internal market. [2002] OJ L 17/20. 169 Ibid, Annex I. 170 Ibid, Annex III. 171 €3 million of such support for the promotion of eggs for human consumption was set by Commission Regulation (EC) No 185/2004 of 2 February 2004 amending Regulation (EC) No 94/2002 laying down detailed rules for applying Council Regulation (EC) No 2826/2000 on information and promotion actions for agricultural products on the internal market. [2004] OJ L 29/4. 172 Article 7 of Regulation 1907/1990 as amended by Council Regulation (EC) No 5/2001 of 19 December 2000 amending Regulation (EEC) No 1907/1990 on certain marketing standards for eggs. [2001] OJ L 2/1.

(H) MacMaolin Ch7

9/2/07

15:17

Page 277

7.5 Conclusion 277 The proper application of, and education about, certification for products of specific character is potentially far more valuable to the EU consumer than the misapplication of the protected geographical indications system ever will be. However, it remains under-used and unheard of by most ‘well-informed, observant and circumspect’ consumers. This book has demonstrated that, despite claims to the contrary, consumer protection and human health preservation are not the primary concerns of EU food law. Free movement remains in the top spot. A reconsideration of this approach, enabling full effect to be given to Articles 30, 152 and 153 EC, is now required to preserve the traditional high quality of European foodstuffs, and to address the key safety concerns raised by unwise dietary habits.

(H) MacMaolin Ch7

9/2/07

15:17

Page 278

(I) MacMaolin index

9/2/07

15:17

Page 279

Index Agreement on Agriculture 144–5 BSE crisis 175–95 beef products 177–8 impact on EU food law and policy 179–85 protective measures 178–9 public anxiety 177 length of incubation period 176 origins 175–6 statistics 176–7 UK inquiry 177–8 White Paper on Food Safety. See White Paper on Food Safety Chocolate vegetable fat in 94–6 Chocolate debate 7–10 British chocolate 7–8 chocolate substitutes 9 cocoa producing countries, and 9–10 raw materials 9 Codex Alimentarius 151–72 accomplishments of 152 Code of Ethics 156–8 consumers, and 157 implementation 158 purpose of 157 requirements 157–8 codes of practice 156 Commission 152–5 operation of 152–5 procedure manual 153–4 purpose 153 rules of procedure 153 subsidiary bodies 154–5 committees 154–5 commodity committees 155 consumer protection, and 172 co-ordinating committees 155 Court of Justice case law 171–2 dietary claims 162–7 misleading 166–7 fair trading, and 172 food labelling standards 158–62 aims of 158 date of minimum durability 161 food name 159 list of ingredients 159–60 net contents 160–61 foodstuff specific standards 170–71

historical development 151–2 horizontal standards 154 importance of 151 nutrition claims 163 nutrition labelling 162–7 misleading claims 166–7 procedures 162 supplementary 162–3 organic production 167–70 certification systems 170 inspection systems 170 labelling requirements 167–70 livestock management 169–70 organic farm system 168 production requirements 169 relationship with EU food law 171–2 relevance of 151 role of standards in international trade regulation 172 special dietary uses 164–5 special medical purposes 165–6 standardisation 151–2 standards 155–71 specification of minimum quality levels 156 vertical standards 154 Common Agricultural Policy 56 Community, role of 56 justification for national rules contrary to Article 28 56 Communication on free movement of food 74–7 importance of foodstuffs sector 74 key features of Community food law framework 76–7 legislation 74–5 mutual recognition of use of additives 76 recognised principles, and 75 trade descriptions 75 Community food safety legislation 203–10 contaminants in food 205–06 minimum acceptable levels 205–6 hygienic production methods 207–10 HACCP principles 208–9 standardised rules 207–8 transportation rules 209–10 irradiated foods 206–7 conditions for authorising 207 materials coming into contact with foodstuffs 203–5 general criteria 204–5

(I) MacMaolin index

9/2/07

15:17

Page 280

280 Index Community legislation on foodstuffs 68–74 Commission, and 69, 70 completing the internal market 68–74 compositional rules 73 consumer protection 72–3 Council, and 69 fair trading 73 food labelling rules 72–3 harmonisation programme 70 public health protection 71–2 purpose of 71 Consumer lobbying effect of 274–5 Contemporary considerations 241–77 Dassonville 20–22 designation of origin, and 22 Directive 1970/50, and 21–2 facts 21 national rules, and 21 protection of consumers 21 Date of minimum durability 89–90 ‘use by’ date 90 Designation of origin 102–22. See also Geographical indications application for registration 104–5 eligibility 104 importance of 106–7 meaning 103 Regulation 510/2006 107–8 third countries 105–6 Ensuring compliance with EU food law 10–11 ‘feed law’ 10–11 meaning 11 Ethical food production 264–74 animal welfare standards 265 calves, protection of 265–6 eggs 266–73 additional labelling requirements 269–70 consumer protection 267–71 egg products, meaning 271–2 ‘free range’ 267, 269 hygiene standards 271–3 labelling descriptions 266 legislative measures 268 marketing standards 267–8 Regulation 2295/2003 268–9 secondary legislation 270–71 welfare standards 267–71 pigs, protection of 265–6 poultry production 273–4 free range 273–4 EU nutrition policy 237–9 Green Paper 238–9 legislative intervention 239 obesity 238–9 ‘supporting environment’ 239

European Food Safety Authority 185–95 advisory forum 190 crisis management 192–5 crisis unit 194 emergencies 192–5 measures 193–4 establishment 188–9 executive director 190 functioning 188–9 general tasks 187 independence and transparency in decisionmaking 192 key elements 187 management board 189–90 mission 188–9 persistent problems 195 rapid alert system 192–5 notifications 193 Regulation 178/2002 187–9 risk analysis 186 risk management 186 scientific committee 190–91 scientific opinions, and 191–2 scientific panels 190–91 structure 189–91 terms of reference 188 Feta cheese cases 108–19 certificates of specific character 117–19 characteristics of feta 113 conditions for regulation, and 110, 112–13 Danish feta 114 Eurobarometer poll 109 Greek national law 113 issues 108–9 manufacturing process 112 nature of generic food names 108–9 factors 110–11 narrowing of definition 115 production of variants 115 registration system, and 116 reinstatement of feta on register 111 relevant Community legislation 114–15 Food additives 210–19 banning free movement, and 212–15 citric acid 213 cochineal 213–14 colours 217–19 Directive 1989/107 215–16 approval 216 general criteria 216 observations 216 scope 215 flavourings 218–19 indigotin 213–14 Italian law 211–12 lactic acid 213

(I) MacMaolin index

9/2/07

15:17

Page 281

Index 281 meaning 215 nisin 212 products imported from another Member State 214–15 rules free movement, and 211–15 sorbic acid 212–13 sweeteners 217–19 Food labelling 77–90 compulsory indications 79 date of mimimum durability 89–90 exclusions 89–90 ‘use by’ date 90 Directive 1979/112 78–9 Directive 2000/13 79–80 framework legislation 78–80 interests in relation to 77–8 labelling, meaning 79–80 language 80–3 provision of information to consumer 81–3 ultimate consumer, and 81 well known product 82 listing ingredients 83–7 additives 84–5 categories 85 compound ingredient 83–4 exceeding requirements 86 fair trading, and 86 form 85 ingredients, meaning 83 quantitative ingredient declarations 87 net quantity 87–9 prepackaged food 88–9 two or more individual prepackaged items 88 Food labelling rules development of 72–3 Food names 90–112 community names 91 ‘eurofoods’ 91 generic names 91–92 restrictions of use 92 ‘geographical’ names 92–3 protected geographical indications and designations of origin 102–22. See also Designations of origin; Geographical indications recipe laws. See Recipe laws sales name 90–91 test of difference 275 Food quality 122–30 butter 127–9 meaning 127 legislation 123–30 margarine 127 meaning 127 milk 126 meaning 126

milk products 126 meaning 126 minced meat 129–30 meaning 129 natural mineral water 123–6 constituents 125–6 labelling 124 meaning 123–4 properties favourable to health 125 requirements 125 spreadable fats 127–8 labelling information 127 structure of law and policy of European Union, and 1–2 Food safety 175–219 BSE crisis 175–95. See also BSE crisis Community legislation. See Community food safety legislation emphasis on 14–15 European Food Safety Authority. See European Food Safety Authority importance of 1 media scares 175 powers of Community institutions 219 precautionary principle 195–203 Community institutions 210–3 environmental law 195–6 evidence requirements 198–200 legislative support 196–8 risk management, and 198–200 scientific advice 201–3 scientific assessment of risk 200 scientific substantiation 198–9 White Paper. See White Paper on Food Safety Free movement of food in the EU 17–65 alteration of labels, and 24 Article 25 18, 57–64 Article 28 17, 19–56 approximation of laws, and 26 feta cheese 27 intra-Community aspect 25–6 Mathot 25 principles on ensuring compliance 28–9 protection of consumers, and 27–8 shape of packaging 28 varieties of product 26–7 wine vinegar 26–7 Article 90 17–18, 57–9 Cassis 17, 22–9 Common Agricultural Policy 56 different products, same name 34–41 clear labelling 36–7 consumer protection arguments 36 human health, and 41 labelling disclosures 40 levels of difference 40–41 lower priced substitutes 37 meat product 39–40

(I) MacMaolin index

9/2/07

15:17

Page 282

282 Index Free movement of food in the EU (cont.): different products, same name (cont.): milk consumption 37–8 milk substitutes 36–9 minimum fat content of cheese 39 mutual recognition 41 pasta ingredients 34–6 proportionality 38–9 effect of 275–7 harmonisation programme 18–19 human health protection, and 18–19, 65 information on labelling 65 measures equivalent to quantitative restrictions 17, 19–56 Cassis 22–3 Dassonville 20–22. See also Dassonville Directive 1970/50 19–20 examples 20 French rules on freezing yoghurt 41–3 indistinctly applicable rules 22–3 national authorisation procedures 49–55 burden of proof 50 conditions justifying 51–52 consumer protection 55 discretion of Member States 51 foodstuffs containing non-authorised chemical products 50–51 French legislation 52–53 genuine risk to human health 51 German beer purity rules 55 procedure 51–2 public health grounds 53–4 risk assessment 51–2, 53–4 sports foodstuffs 50 vitamin-enriched foods 54 national quality requirements 29–34 alcohol content 30–31 Dutch cheese 29–30 German beer quality rules 33–4 harmonisation, and 32 jenever 30–31 Kaas 29–30 marketing advantage 29–30 standards properly upheld 32 new rules on health and nutrition claims 18–19, 226–32 obesity crisis, and 275 post-Cassis 23–9 principles 11–12, 15 protecting human health under Article 30 EC 45–9. See also protecting human health under Article 30 EC safeguarding consumer interests, and 65 substantial difference between food products 41–4 consumer expectation 43 foie gras 44

French rules on deep-freezing of yoghurt 41–3 mandatory requirement exception 41–3 minimum fat content of cheese 43 mutual recognition of generic names 44 trade impediment 42 taxation 57–64 compatibility with Article 90 57–64 competitive products 58 consumer preferences, and 57–8 different rates of tax 57–8 inspection of products 60–63 internal taxation on imported foodstuffs 57–9 Italian charge on banana consumption 59 measures equivalent to customs duties 60–64 authorisation costs 63–4 charges for inspecting imported poultry meat 61 dilemma of Member State 63 veterinary inspection charges 60–61, 61–2 unfair charge 58–9 unjustifiable national compositional requirements 23–4 Fruit juices concentrates 97–8 meaning 98 Genetic modification 241–54 challenging regulatory framework 251–4 Deliberate Release Directive 246–7 compulsory notification procedure 246–7 environmental concerns 242 Genetically Modified Food and Feed Regulation 247–50 authorisation procedure 247–50 genetically modified food 15 genetically modified organisms, meaning 241–2 human health, and 242–3 Labelling and Traceability Regulation 250–51 labelling requirements 251 traceability requirements 250 labelling difficulties 251–4 new regulatory regime 254 soya and maize products 252–3 legal framework 243–54 Novel Foods Regulation 244–5 labelling requirements 245 safeguard clause 245 organic food, and. See Organic food regulatory framework 243–54 Geographical indications 102–22. See also Designations of origin application for registration 104–5 certificates of specific character 117–19

(I) MacMaolin index

9/2/07

15:17

Page 283

Index 283 feta, and 117–18 national laws, and 118 compatibility of protecting names with Article 28 121–2 eligibility 104 fair and traditional use by third parties 122 feta cheese cases. See Feta cheese cases importance of 106–7 meaning 103 pasta 115–16 protection for geographical names under Regulation 510/2006 119–21 epoisses de bourgogne 120–21 ‘evocation’ 120 Gorgonzola 119–20 parma ham 120 Regulation 510/2006 107–8 third countries 105–6 TRIPs Agreement. See TRIPs Agreement Globalisation effect 2, 275 HACCP principles 208–9 Harmonising food standards in the EU 67–131 Cassis, before 67–8 Community legislation on foodstuffs. See Community legislation on foodstuffs Communication on free movement of food. See Communication on free movement of food food labelling 77–90. See also Food labelling food names 90–122. See also Food names food quality. See Food quality free movement, and 130–31 Historical development of food law 2–5 Adulteration of Food or Drink Act 1860 3 early UK statutes 3 early writings 2–3 EC Treaty, and 5 nineteenth century 3–4 recipe laws 4–5 Honey 99–101 Codex Alimentarius 101 compositional criteria 100 country of origin 100 meaning 99 monitoring procedure 100 types 99 Importance of food sector in EU 5–11 chocolate debate. See Chocolate debate statistics 5–6 trade in food as major political issue 6 Ingredients listing. See Food labelling meaning 83

Innovation in food production 241–54. See also Genetic modification Instant coffee meaning 96 International influences 133–73 persuasive authority 172–3 WTO Agreements 133–45. See also WTO Agreements International trade rules governing 13–14 Jams recipe laws 101–2 Labelling meaning 79–80 Mutual recognition principle of 1, 12 Nutrition labelling 225–6 meaning 225 Nutrition law and policy 221–40 authorisation procedure 230–32 Community register 231–2 modifications 231 opinion of EFSA 230–31 Commission, and 223 Community legislation 225–33 EU nutrition policy 237–9. See also EU nutrition policy focus of European food law, and 221–2 folic acid fortification 235–7 Ireland 236–7 food supplements 232–3 labelling 232 meaning 233 forms 225–6 free movement, and 234–9 health claims 226–32 key provisions of nutrition and health claims legislation 228–30 beneficial nutritional or physiological effect 229 categories of nutrition claims 230 nutrition claim, meaning 228 nutrient profiles 228–9 Member State autonomy in health protection measures 237 Member States, in 234–7 obesity, and 224, 239–40 priorities of consumers, and 223–4 Regulation on Nutrition and Health Claims 226–8 background 226–8 guidelines at international levels, and 227 technological innovation, and 227

(I) MacMaolin index

9/2/07

15:17

Page 284

284 Index Nutrition law and policy (cont.): UK White Paper on Public Health. See UK White Paper on Public Health Organic food 15, 254–64 demand for 254–64 farm rules 255–6 future regulation of production 263–4 genetic modifications, and 260–63 coexistence 262–3 consumer protection, and 260–61 economic aspects 262 general principles 262–3 national strategies 263 livestock production 256–60 force feeding 257 housing conditions 259 poultry 259–60 prevention of disease 257–8 rearing standards 257 reproduction 258–9 slaughter 259 stocking density levels 259 production rules 255–6 statistics 254 Prepackaged meaning 88–9 Protecting human health under Article 30 EC 45–9 additives in food 47–8 ban on marketing of meat products 45–6 bread with high salt content 46–7 clear danger 49 exceptions to Article 28 45–9 German beer purity rules 47–8 marketing of milk substitutes 48–9 pasta ingredients 49 proteins in meat 45–6 Quantitative ingredient declarations 87 Recipe laws 93–102 chicory 90–97 chocolate 94–6 cocoa 94–6 coffee 96–7 decaffeinated 96 instant 96 fruit juices 97–8 honey. See Honey jams 101–2 Regulating the food industry 1–15 Secondary legislation 13 SPS Agreement 138–42 ‘measures’ 139

adapted to characteristics of area 141 appropriate assessment of risks 140 decisions on appropriate level of protection 140 international standards, and 139 potential impact on EU food law and policy 141–2 sanitary or phytosanitary measures, meaning 138 scope 138–9 Taxation free movement of food, and. See Free movement of food in the EU TBT Agreement 142–4 committee on technical barriers to trade 144 technical regulations 142–4 Code of Good Practice 143–4 international standards, and 142–3 meaning 142 TRIPs Agreement 134–8 aim 135–6 geographical indications 136–8 exceptions 137 wine and spirits 136–7 UK White Paper on Public Health 234–5 signpost labelling system 234–5 voluntary nature of 235 White Paper on Food Safety 179–85 animal health and welfare 182–3 controls over operation of EU legislation 184–5 creation of set of food safety rules 181–2 emergency measures 183–4 EU policy on food safety 179–80 ‘farm to fork’ approach 182 guiding principle 180–81 internal market, role of 180 organization of food safety 180 origin 179 regulatory aspects 181–2 timetable for action 180 World Trade Organization 133–50 dispute settlement 145–9 appeals 148 arbitration 149 complaint 146 covered agreements 146 draft report 147–8 GATT, and 145 panels 147 prompt compliance with recommendations or rulings 148–9 effect of rules on EU food law 149–50 precautionary principle, and 50 protection of geographical food names 150

(I) MacMaolin index

9/2/07

15:17

Page 285

Index 285 negotiating forum, as 134 WTO Agreements 133–45 Agreement on Agriculture 144–5 EU food law, and 135–45 global free trade, and 133–45

SPS Agreement. See SPS Agreement TBT Agreement 142–4. See also TBT Agreement TRIPs Agreement 134–8. See also TRIPs Agreement